Novartis AG

Aug 19, 2026

NVSConferences/Events

Novartis data at ESC Congress 2026 reinforce cardiovascular leadership and showcase progress in next-generation therapies

Novartis will present significant cardiovascular data at the 2026 ESC Congress, emphasizing its leadership in the field. Key studies include the VICTORION-CHALLENGE data on Leqvio and analyses of abelacimab's bleeding profile. The company aims to advance cardiovascular care through innovative therapies and a strong pipeline.

Jul 21, 2026

Novartis delivered sales growth in Q2 and further advanced the pipeline; Full-year guidance reaffirmed

Novartis reported a 1% increase in net sales for Q2 2026, driven by strong performances from priority brands such as Kisqali and Leqvio. Despite a decline in net income and operating income, the company reaffirmed its full-year guidance, expecting low single-digit growth. Notable pipeline advancements include FDA submissions and approvals for new therapies.

Jul 16, 2026

Novartis Fabhalta® (iptacopan) receives FDA traditional approval as first and only complement inhibitor to significantly slow kidney function decline in primary IgAN

Novartis has received FDA traditional approval for Fabhalta (iptacopan), the first complement inhibitor to significantly slow kidney function decline in adults with primary IgAN. The approval is based on the Phase III APPLAUSE-IgAN study, which demonstrated a 48% reduction in eGFR decline compared to placebo. This milestone is expected to provide renewed hope for patients suffering from this progressive disease.

Jul 13, 2026

Chai Discovery Announces Collaboration with Novartis to Advance AI-Driven Antibody Discovery

Chai Discovery has announced a collaboration with Novartis focused on advancing AI-driven antibody discovery. This partnership aims to leverage artificial intelligence to enhance the efficiency and effectiveness of antibody development. The collaboration signifies a strategic move in the biopharma sector, potentially leading to innovative therapeutic solutions.

Jul 6, 2026

Sofinnova Partners Announces Myricx Bio Agrees to Be Acquired by Novartis

Sofinnova Partners has announced that Myricx Bio has agreed to be acquired by Novartis. This acquisition is expected to bolster Novartis' capabilities in the biopharmaceutical sector. The deal highlights Novartis' commitment to expanding its portfolio and enhancing its market position.

Jul 6, 2026

Myricx Bio to be Acquired by Novartis to Advance Next-Generation ADC Payloads for Oncology with Novel NMTi Platform

Myricx Bio has announced its acquisition by Novartis for up to $1.5 billion, including $1.1 billion in cash upfront. This acquisition aims to leverage Novartis's oncology expertise and Myricx's innovative N-myristoyltransferase inhibitor (NMTi) payload platform, which has potential applications across various solid tumors. The deal is expected to close in the second half of 2026, pending regulatory approvals.

Jul 6, 2026

Novartis agrees to acquire Myricx Bio, advancing next-generation antibody-drug conjugate innovation with a novel NMTi payload, expanding options for cancer patients

Novartis has announced its agreement to acquire Myricx Bio, a UK-based biotech company specializing in antibody-drug conjugates (ADCs) with a novel N-myristoyltransferase inhibitor (NMTi) payload. This acquisition aims to enhance Novartis' oncology pipeline and address limitations of current ADC payloads. The deal involves an upfront payment of $1.1 billion, with additional milestone payments possible, and is expected to close in the second half of 2026, pending regulatory approvals.

Jul 2, 2026

Novartis receives European Commission approval for Itvisma® for spinal muscular atrophy (SMA)

Novartis has received European Commission approval for Itvisma, the first gene replacement therapy for spinal muscular atrophy (SMA) in the EU. This treatment is designed for children aged two and older, as well as teens and adults, and aims to replace the faulty SMN1 gene with a one-time fixed dose. The approval is based on positive results from clinical studies, marking a significant advancement for SMA patients.

Jun 24, 2026

Becoming rentABLE Joins Novartis' "SMAshing My Limits And Going Places" Campaign to Expand Accessible Lodging for People Living with SMA

Novartis has partnered with Becoming rentABLE to enhance accessible travel for individuals living with spinal muscular atrophy (SMA). The collaboration aims to add around 100 verified accessible short-term rentals across the U.S., addressing the significant lack of such accommodations. This initiative reflects a commitment to improving travel experiences for the SMA community, offering unique properties that cater to their specific needs.

Jun 24, 2026

Antares Therapeutics Enters Agreement with Novartis to Discover, Develop and Commercialize First-in-Class Cancer Therapies

Antares Therapeutics has entered into an agreement with Novartis to collaborate on the discovery, development, and commercialization of innovative cancer therapies. This partnership aims to leverage both companies' expertise to create first-in-class treatments for cancer. Details regarding the specific therapies or financial terms of the agreement have not been disclosed.

Jun 12, 2026

Novartis RemIND data at EAACI show Rhapsido® potential as first targeted therapy for chronic inducible urticaria (CIndU)

Novartis presented data from the RemIND trial at the EAACI Congress, showing that Rhapsido (remibrutinib) significantly improved symptom control in patients with chronic inducible urticaria (CIndU). This marks Rhapsido as the first targeted therapy for CIndU, with a favorable safety profile. The drug is currently under FDA review for the symptomatic dermographism subtype, with additional global submissions planned for 2026.

Jun 11, 2026

NVSPhases

Novartis delpacibart braxlosiran (del-brax) Phase I/II study in facioscapulohumeral muscular dystrophy (FSHD) meets primary biomarker endpoint

Novartis announced that its delpacibart braxlosiran (del-brax) met primary and key secondary endpoints in the FORTITUDE Phase I/II study for facioscapulohumeral muscular dystrophy (FSHD). The study demonstrated significant reductions in KHDC1L and creatine kinase levels, indicating potential disease modification. Novartis plans to engage with regulatory authorities as it progresses to Phase III trials.

Jun 8, 2026

NVSConferences/Events

Novartis to highlight Rhapsido® data across multiple immune-mediated diseases at EAACI Congress 2026

Novartis will present significant data on Rhapsido (remibrutinib) at the EAACI Congress 2026. Key highlights include results from the Phase III RemIND trial for chronic inducible urticaria and extension data from the Phase IIIb REMIXED trial. Additionally, a Phase II dose-response analysis for peanut allergy will be showcased, emphasizing Rhapsido's potential across various immune-mediated diseases.

Jun 4, 2026

NVSPhases

Novartis IgAN data in The Lancet show clinically meaningful slowing of kidney function decline with Vanrafia® over 2.5 years

Novartis announced positive results from the Phase III ALIGN study, demonstrating that Vanrafia (atrasentan) significantly slows kidney function decline in adults with IgA nephropathy over 2.5 years. The study showed a 34% reduction in the rate of decline compared to placebo, alongside a substantial decrease in proteinuria. These findings reinforce Vanrafia's potential as a foundational therapy for IgAN.

Jun 3, 2026

Novartis Cosentyx® PMR data in New England Journal of Medicine showed sustained remission vs placebo in twice as many patients

Novartis announced that Cosentyx (secukinumab) demonstrated significant efficacy in treating polymyalgia rheumatica (PMR), achieving sustained remission rates that were statistically superior to placebo. The Phase III REPLENISH trial results were published in the New England Journal of Medicine and presented at the EULAR Congress. Cosentyx also showed potential for reducing steroid use among patients. Regulatory submissions for Cosentyx in PMR are underway in multiple regions.

Sep 30, 2025

Novartis receives FDA approval for Rhapsido® (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU)

Novartis has received FDA approval for Rhapsido® (remibrutinib), the first oral BTK inhibitor for chronic spontaneous urticaria (CSU). This treatment offers a unique approach, providing fast symptom relief without the need for injections or lab monitoring, and expands options for patients who remain symptomatic despite antihistamine treatment.

Jun 18, 2025

Incyte Announces FDA Approval of Monjuvi® (tafasitamab-cxix) in Combination with Rituximab and Lenalidomide for Patients with Relapsed or Refractory Follicular Lymphoma | Incyte

Incyte announced FDA approval of Monjuvi® (tafasitamab-cxix) in combination with rituximab and lenalidomide for relapsed or refractory follicular lymphoma. The approval is based on significant improvements in progression-free survival from clinical trials, marking a new treatment option for patients.

Apr 2, 2025

Novartis receives FDA accelerated approval for Vanrafia® (atrasentan), the first and only selective endothelin A receptor antagonist for proteinuria reduction in primary IgA nephropathy (IgAN)

Novartis received FDA accelerated approval for Vanrafia® (atrasentan), the first selective endothelin A receptor antagonist for reducing proteinuria in IgA nephropathy. Phase III data showed significant proteinuria reduction, and it can be integrated into existing treatment plans without a REMS requirement.

Mar 28, 2025

FDA approves Novartis radioligand therapy Pluvicto® for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer

The FDA has approved Novartis' Pluvicto for earlier use in treating PSMA-positive metastatic castration-resistant prostate cancer, significantly expanding the eligible patient population and demonstrating clinical benefits in delaying disease progression.

Mar 20, 2025

Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G)

Novartis has received FDA approval for Fabhalta® (iptacopan), the first oral treatment for C3 glomerulopathy, showing significant proteinuria reduction and a favorable safety profile. This approval marks a historic advancement for patients suffering from this ultra-rare kidney disease.

Oct 29, 2024

Novartis Secures First-Line CML Expansion for Scemblix, Projects $3B in Peak Sales

Novartis received FDA accelerated approval for Scemblix, expanding its use in newly diagnosed chronic myeloid leukemia patients. This approval significantly increases the eligible patient population and is projected to drive peak sales over $3 billion. The drug demonstrated superior efficacy in clinical trials compared to standard treatments.

Sep 17, 2024

FDA awards Novartis expanded approval for breast cancer therapy

The FDA has granted Novartis expanded approval for Kisqali, allowing its use in certain early-stage breast cancers. This approval significantly increases patient access and reduces recurrence risk by 28.5%, although the drug does have some side effects.

Aug 7, 2024

Novartis receives FDA accelerated approval for Fabhalta® (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy (IgAN)

Novartis received FDA accelerated approval for Fabhalta® (iptacopan), the first complement inhibitor for reducing proteinuria in primary IgA nephropathy. The drug showed a 44% reduction in proteinuria in a Phase III study, compared to 9% in the placebo group, although further verification of its clinical benefits is required.

Apr 23, 2024

Novartis radioligand therapy Lutathera® FDA approved as first medicine specifically for pediatric patients with gastroenteropancreatic neuroendocrine tumors

Novartis announced FDA approval of Lutathera® for pediatric patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), marking it as the first therapy specifically for this group. The approval is based on the NETTER-P trial, demonstrating a consistent safety profile and addressing a critical need for treatment options in this rare cancer.

Oct 31, 2023

FDA approves Novartis Cosentyx® as the first new biologic treatment option for hidradenitis suppurativa patients in nearly a decade

The FDA has approved Novartis' Cosentyx as the first new biologic treatment for hidradenitis suppurativa in nearly a decade, offering rapid symptom relief and a new option for patients suffering from this chronic disease.

Oct 6, 2023

FDA approves Novartis Cosentyx® as first intravenous (IV) formulation interleukin-17A antagonist for rheumatic diseases

The FDA has approved Novartis' Cosentyx® as the first intravenous formulation for treating psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. This new option enhances treatment flexibility and is backed by extensive clinical research.

Jun 22, 2022

Novartis Tafinlar + Mekinist receives FDA approval for first tumor-agnostic indication for BRAF V600E solid tumors

Novartis' Tafinlar + Mekinist has received FDA approval as the first tumor-agnostic therapy for solid tumors with BRAF V600E mutations, showing up to 80% response rates in clinical trials. This approval includes use in pediatric patients, marking a significant advancement in cancer treatment options.

Apr 5, 2022

FDA approves Novartis Vijoice® (alpelisib) as first and only treatment for select patients with PIK3CA-Related Overgrowth Spectrum (PROS)

The FDA has approved Novartis' Vijoice® (alpelisib) as the first treatment for PIK3CA-Related Overgrowth Spectrum (PROS) in patients aged 2 and older. The approval is based on real-world data showing significant reductions in PROS lesions and improvements in related symptoms.

Mar 23, 2022

Novartis Pluvicto™ approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA-positive metastatic castration-resistant prostate cancer

Novartis' Pluvicto™ has been approved by the FDA as the first targeted radioligand therapy for progressive, PSMA-positive metastatic castration-resistant prostate cancer. This approval is based on the Phase III VISION trial, showing significant survival benefits for patients with limited treatment options.

Nov 1, 2021

FDA approves Novartis Scemblix® (asciminib), with novel mechanism of action for the treatment of chronic myeloid leukemia

The FDA has approved Novartis' Scemblix (asciminib) for chronic myeloid leukemia, providing a new treatment option for patients resistant to existing therapies. The approval is based on positive trial results, although continued approval may depend on further evidence.

Feb 16, 2021

Novartis Entresto® granted expanded indication in chronic heart failure by FDA

The FDA has granted Novartis' Entresto an expanded indication for treating chronic heart failure, now including patients with both reduced and preserved ejection fraction. This approval allows for a broader range of patients to receive treatment, addressing a significant unmet need in heart failure care.

Dec 18, 2020

Novartis receives complete response letter from U.S. FDA for inclisiran

Novartis received a complete response letter from the FDA for inclisiran, citing unresolved facility inspection conditions but raised no concerns about its efficacy or safety. The company plans to work with the FDA and the manufacturing facility to resolve these issues and expedite the review process.

Aug 20, 2020

FDA approves Novartis Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis

The FDA has approved Novartis' Kesimpta (ofatumumab) as the first self-administered B-cell therapy for relapsing multiple sclerosis, offering superior efficacy and a favorable safety profile. This treatment allows patients to self-administer monthly injections at home, improving convenience and potentially enhancing patient outcomes.

Nov 15, 2019

New Novartis medicine Adakveo® (crizanlizumab) approved by FDA to reduce frequency of pain crises in individuals living with sickle cell disease

The FDA has approved Novartis' Adakveo® (crizanlizumab) to reduce pain crises in sickle cell disease patients. The drug showed a 45% reduction in annual pain crises and is expected to be available soon, marking a significant advancement in treatment options.

Oct 8, 2019

Novartis receives FDA approval for Beovu®, offering wet AMD patients vision gains and greater fluid reductions vs aflibercept

Novartis received FDA approval for Beovu® (brolucizumab) for treating wet AMD, demonstrating non-inferior vision gains compared to aflibercept and greater fluid reductions. Beovu allows for three-month dosing intervals, potentially improving patient adherence and treatment outcomes.

May 24, 2019

FDA approves Novartis Piqray® – the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer | Novartis

The FDA has approved Novartis' Piqray, the first treatment specifically for HR+/HER2- advanced breast cancer patients with a PIK3CA mutation. Clinical trials showed it nearly doubled median progression-free survival compared to existing treatments, marking a significant advancement in personalized cancer therapy.

Mar 26, 2019

Novartis receives FDA approval for Mayzent® (siponimod), the first oral drug to treat secondary progressive MS with active disease | Novartis

Novartis has received FDA approval for Mayzent® (siponimod), the first oral treatment for active secondary progressive multiple sclerosis (SPMS) in over 15 years. The approval is based on the Phase III EXPAND trial, demonstrating significant efficacy in reducing disease progression and improving patient outcomes.

Feb 14, 2019

Novartis' Busy Day: 10-Target Deal With AbCellera and FDA Approves Parasite Drug

Novartis received FDA approval for Egaten to treat fascioliasis and announced a collaboration with AbCellera for antibody discovery. The approval is seen as a significant step in addressing a neglected tropical disease, with WHO support for the drug's distribution.

Jan 30, 2019

t!J NOVARTIS B | PROPOSED SPIN-OFF OF ALCON Important Information This information brochure has been prepared exclusively for the shareholders of Novartis AG and holders of Novartis American Depositary Receipts ( ADRs )

B | PROPOSED SPIN-OFF OF ALCON Important Information This information brochure has been prepared exclusively for the shareholders of Novartis AG and holders of Novartis American Depositary Receipts ( ADRs ) in connection with the spin-off of Alcon proposed to the annual general m

Nov 16, 2018

FDA approves Novartis drug Promacta® for first-line SAA and grants Breakthrough Therapy designation for additional new indication

The FDA has approved Novartis' Promacta® for first-line treatment of severe aplastic anemia (SAA) and granted Breakthrough Therapy designation for low platelet counts due to radiation exposure. The approval is based on significant response rates in patients, marking a major advancement in treatment options for SAA.

Oct 18, 2018

Amidst Strong Quarterly Growth, Novartis Receives FDA Complete Response Letter for Canakinumab

Novartis reported a 6% growth in net sales, driven by strong performance of Cosentyx and other drugs. However, the company received a Complete Response Letter from the FDA for canakinumab, marking a setback. Despite this, Novartis highlighted several clinical successes and acquisitions during the quarter.

Jul 18, 2018

Novartis Kisqali® now first and only CDK4/6 inhibitor indicated in US as first-line therapy specifically for premenopausal women; and as initial therapy with fulvestrant in postmenopausal women | Novartis

Novartis announced FDA approval for Kisqali as the first and only CDK4/6 inhibitor for premenopausal women and in combination with fulvestrant for postmenopausal women with HR+/HER2- advanced breast cancer. This approval is based on positive results from clinical trials, offering new treatment options for patients.

Jun 19, 2018

Novartis receives FDA approval for inclusion of new evidence that Cosentyx® inhibits progression of joint structural damage in psoriatic arthritis

Novartis announced FDA approval for Cosentyx® to include new evidence showing it significantly slows joint structural damage in psoriatic arthritis. This update enhances prescribing information and reinforces the drug's role in managing the disease.

May 11, 2018

Novartis announces FDA approval of Gilenya® as the first disease-modifying therapy for pediatric relapsing multiple sclerosis

Novartis announced FDA approval of Gilenya for children and adolescents with relapsing multiple sclerosis, marking it as the first disease-modifying therapy for this age group. The approval follows a study showing an 82% reduction in relapse rates, providing a significant treatment option for younger patients.

May 4, 2018

Novartis receives FDA approval of Tafinlar® + Mekinist® for adjuvant treatment of BRAF V600-mutant melanoma

Novartis has received FDA approval for Tafinlar® and Mekinist® as the first oral targeted adjuvant therapy for BRAF V600-mutant melanoma, showing a 53% reduction in disease recurrence risk. This approval offers a new treatment option for patients at risk of recurrence following surgery.

May 2, 2018

Sandoz receives complete response letter from the US FDA for proposed biosimilar rituximab

Sandoz announced that the FDA issued a complete response letter for its proposed biosimilar rituximab. While disappointed, Sandoz is committed to further discussions with the FDA and emphasizes the need for access to effective therapies.

Apr 10, 2018

Novartis drug Afinitor DISPERZ® receives FDA approval to treat TSC-associated partial-onset seizures

Novartis' Afinitor DISPERZ has received FDA approval for treating TSC-associated partial-onset seizures in patients aged two and older. This marks the first pharmacologic therapy approved for this condition in the US, demonstrating significant efficacy in reducing seizure frequency in clinical trials.

Jan 26, 2018

Advanced Accelerator Applications Receives US FDA Approval for LUTATHERA® for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

Advanced Accelerator Applications has received FDA approval for LUTATHERA®, a first-in-class therapy for treating gastroenteropancreatic neuroendocrine tumors. The approval is based on a Phase 3 study showing a 79% improvement in progression-free survival, marking a significant advancement in treatment options for patients.

Jun 22, 2017

Novartis combination targeted therapy Tafinlar® + Mekinist® receives FDA approval for BRAF V600E mutant metastatic non-small cell lung cancer (NSCLC)

Novartis' Tafinlar® and Mekinist® received FDA approval for treating BRAF V600E mutant metastatic non-small cell lung cancer. The combination therapy shows promising response rates and addresses a significant need for targeted treatments in this aggressive cancer type.

May 26, 2017

Novartis receives FDA approval for expanded use of Zykadia® in first-line ALK-positive metastatic non-small cell lung cancer (NSCLC)

Novartis announced FDA approval for Zykadia's expanded use as a first-line treatment for ALK-positive metastatic non-small cell lung cancer. The approval is based on positive results from the ASCEND-4 trial, showing significant improvements in progression-free survival and overall response rates compared to standard chemotherapy.

May 4, 2017

Novartis receives FDA approval for first-of-its-kind Kisqali® Femara® Co-Pack for initial treatment of HR+/HER2- advanced or metastatic breast cancer

Novartis has received FDA approval for the Kisqali Femara Co-Pack, a unique combination pack for treating HR+/HER2- advanced breast cancer in postmenopausal women. This approval offers physicians a convenient prescribing option and underscores Novartis's commitment to innovative cancer treatments.

Apr 28, 2017

Novartis receives FDA approval for Rydapt® in newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of systemic mastocytosis (SM) | Novartis

Novartis has received FDA approval for Rydapt® to treat newly diagnosed FLT3-mutated acute myeloid leukemia and three types of systemic mastocytosis. This marks the first new treatment for FLT3-mutated AML in over 25 years, demonstrating significant survival benefits in clinical trials.

Mar 13, 2017

Novartis Kisqali® (ribociclib, LEE011) receives FDA approval as first-line treatment for HR+/HER2- metastatic breast cancer in combination with any aromatase inhibitor | Novartis

Novartis' Kisqali® (ribociclib) has received FDA approval as a first-line treatment for HR+/HER2- metastatic breast cancer in combination with any aromatase inhibitor, showing significant efficacy in clinical trials, including a 44% reduction in disease progression risk compared to letrozole alone.

Sep 23, 2016

Novartis receives three new FDA approvals for the expanded use of Ilaris® treating rare Periodic Fever Syndrome conditions | Novartis

Novartis announced that the FDA has granted three approvals for Ilaris® to treat TRAPS, HIDS/MKD, and FMF, marking it as the first biologic treatment for these conditions. The approvals follow Breakthrough Therapy Designations and highlight the significant unmet need for effective treatments in rare Periodic Fever Syndromes.

Feb 26, 2016

FDA approves new indication for Novartis drug Afinitor® for progressive, nonfunctional GI and lung neuroendocrine tumors (NET) | Novartis

The FDA has approved Afinitor® for treating progressive, nonfunctional neuroendocrine tumors (NET) of gastrointestinal and lung origin, marking a significant advancement in treatment options for these rare cancers.

Nov 20, 2015

Novartis receives FDA regular approval for Tafinlar® + Mekinist® to treat aggressive form of melanoma based on long-term survival data

Novartis announced FDA regular approval for Tafinlar® + Mekinist® to treat BRAF V600E/K mutation-positive unresectable or metastatic melanoma, based on long-term survival data. This combination therapy has shown significant clinical benefits, extending patient lives and improving outcomes in clinical trials.

Oct 29, 2015

in the Report on Form 6-K of Novartis AG furnished to the Securities and Exchange Commission on

Novartis continued to strengthen the pipeline in Q3; on track for full-year guidance Q3 net sales for continuing operations 2 declined in USD, but showed solid growth in constant currencies (cc 1 ) o Net sales were USD 12.3 billion (-6%, +6% cc) o Operating income was USD 2.2

Jun 11, 2015

Novartis gains FDA approval for Promacta® providing new option for children, ages 6 and older, with chronic ITP, a rare blood disorder

Novartis received FDA approval for Promacta® to treat children aged 6 and older with chronic ITP, a rare blood disorder. This approval offers a new treatment option for patients who have not responded adequately to existing therapies.

Mar 30, 2015

Novartis announces FDA approval for Jadenu(TM) to simplify treatment administration for patients with chronic iron overload

Novartis announced FDA approval for Jadenu, a new oral formulation of Exjade, to treat chronic iron overload in patients aged 2 and older. Jadenu simplifies treatment with once-daily administration, addressing patient needs for easier therapy options.

Apr 30, 2014

Back To The Drawing Board For The Medicines Company, As The FDA Denies Antiplatelet Agent Cangrelor

The Medicines Company received a Complete Response Letter from the FDA denying the new drug application for its antiplatelet agent cangrelor, citing the need for further clinical data analyses and studies to assess its benefit-risk relationship.

Apr 29, 2014

Novartis gains FDA approval for Zykadia™, first therapy for patients with ALK+ NSCLC previously treated with the ALK inhibitor crizotinib

Novartis received FDA approval for Zykadia™ to treat ALK+ NSCLC patients who have progressed on crizotinib. This approval provides a new treatment option addressing an unmet medical need, with a reported overall response rate of 54.6% in clinical trials.

Jun 27, 2013

Novartis Exelon® Patch now FDA approved to treat patients across all stages of Alzheimer's disease

The FDA has approved Novartis' Exelon® Patch for treating all stages of Alzheimer's disease, including severe cases. This marks a significant advancement in treatment options, supported by clinical study results showing improved cognition and function. However, there are potential adverse reactions and serious side effects associated with its use.

May 9, 2013

Novartis drug Ilaris® approved by FDA to treat active systemic juvenile idiopathic arthritis, a serious form of childhood arthritis

Novartis' Ilaris has been approved by the FDA for treating active systemic juvenile idiopathic arthritis in children aged 2 and older. This marks the first approval of an IL-1 beta inhibitor for this condition, showing significant patient improvement and potential to reduce corticosteroid use.

Feb 15, 2013

Novartis drug Zortress® is first in over a decade approved by FDA to prevent organ rejection in adult liver transplant patients

Novartis' Zortress® has received FDA approval for preventing organ rejection in adult liver transplant patients, marking the first new immunosuppressant in over a decade. This approval highlights Novartis' ongoing innovation in the transplant field and offers a promising treatment option that may improve renal function.

Jan 25, 2013

FDA Gives Nod to Novartis AG's Gleevec for Pediatric ALL

The FDA has approved Novartis' Gleevec for treating pediatric patients with Ph+ acute lymphoblastic leukemia (ALL), a significant advancement in pediatric cancer treatment. Clinical trials showed promising results, with a high percentage of patients experiencing event-free survival.

Jan 23, 2013

FDA Approves Novartis AG's Exjade in Patients With Genetic Blood Disorder

The FDA has approved Novartis AG's Exjade for treating patients with non-transfusion-dependent thalassemia (NTDT) who show iron overload. This approval includes the use of FerriScan as a diagnostic tool to monitor treatment. Exjade's efficacy was demonstrated in clinical trials, allowing for earlier patient access through the FDA's accelerated approval program.

Jul 20, 2012

Novartis gains FDA approval for Afinitor® in advanced breast cancer marking a significant milestone for women battling this disease

Novartis received FDA approval for Afinitor® to treat advanced hormone receptor-positive, HER2-negative breast cancer in postmenopausal women. This marks a significant advancement in treatment options, significantly improving progression-free survival rates. The approval is based on a pivotal trial demonstrating Afinitor's effectiveness in combination with exemestane.

Apr 26, 2012

FDA approves Votrient® for treatment of patients with certain types of advanced soft tissue sarcoma

The FDA has approved Votrient (pazopanib) for treating advanced soft tissue sarcoma in patients who have received prior chemotherapy. This approval marks a significant addition to treatment options for this rare cancer, although efficacy for specific sarcoma types remains unproven.

Apr 26, 2012

Novartis drug Afinitor® approved by FDA as first medication to treat patients with non-cancerous kidney tumors associated with TSC

Novartis' Afinitor® has been approved by the FDA as the first treatment for adult patients with non-cancerous kidney tumors associated with tuberous sclerosis complex (TSC). The approval is based on significant clinical trial results showing improved patient outcomes.

Jan 31, 2012

FDA Approves Gleevec For Expanded Use in Patients With Rare Gastrointestinal Cancer

The FDA has approved Gleevec for expanded use in patients with CD117-positive gastrointestinal stromal tumors, showing improved survival rates with longer treatment durations. The approval underscores the importance of ongoing studies to assess drug benefits.

Jul 1, 2011

FDA Approves Novartis Pharmaceuticals Corporation's Arcapta Neohaler to Treat Chronic Obstructive Pulmonary Disease

The FDA has approved Novartis' Arcapta Neohaler for treating Chronic Obstructive Pulmonary Disease (COPD), offering a new option for patients. The drug helps relax airway muscles to alleviate symptoms. However, it carries a warning regarding asthma-related risks.

May 5, 2011

Novartis Gains FDA Approval for Afinitor® as First New Treatment in Nearly Three Decades for Patients with Advanced Pancreatic NET

Novartis received FDA approval for Afinitor® to treat advanced pancreatic neuroendocrine tumors, marking the first new treatment in nearly 30 years. The approval is based on Phase III trial data showing significant improvements in tumor growth delay and disease progression risk reduction.

Dec 21, 2010

Novartis Gains FDA Approval for Amturnide™, a Triple-Combination Pill to Treat High Blood Pressure in Patients Uncontrolled on Two Medications

Novartis received FDA approval for Amturnide, a triple-combination pill for high blood pressure, showing significant efficacy in clinical trials. This treatment option is aimed at patients not adequately controlled on two medications, combining a direct renin inhibitor, a calcium channel blocker, and a diuretic.

Oct 29, 2010

Novartis Drug Afinitor® Approved by FDA as First Medication for Children and Adults with a Benign Brain Tumor Associated with Tuberous Sclerosis

Novartis' Afinitor has been approved by the FDA for treating subependymal giant cell astrocytoma in patients with tuberous sclerosis. This marks a significant advancement in treatment options, especially for children and adolescents, with 32% of patients showing a notable reduction in tumor size.

Sep 21, 2010

Novartis gains FDA approval for Gilenya™, a novel first-line multiple sclerosis treatment shown to significantly reduce relapses and delay disability progression

Novartis received FDA approval for Gilenya, the first oral treatment for relapsing forms of multiple sclerosis in the US. Clinical trials demonstrated a 52% reduction in relapses and a well-studied safety profile, marking a significant advancement for MS patients.

Aug 26, 2010

Novartis receives FDA approval of Tekamlo(TM), a single-pill combination of aliskiren and amlodipine to treat high blood pressure

Novartis received FDA approval for Tekamlo, a single-pill combination of aliskiren and amlodipine for high blood pressure. Clinical trials showed significant blood pressure reductions compared to individual medications, providing a new treatment option for patients needing multiple therapies.

Jun 17, 2010

FDA Approves Tasigna® for Newly Diagnosed Chronic Myeloid Leukemia Patients, Data Demonstrate Major Advance Over Gleevec®

The FDA has approved Tasigna® for newly diagnosed chronic myeloid leukemia patients, marking a significant advancement over Gleevec®. Clinical trials show Tasigna offers improved efficacy and response rates, although further data is needed for long-term outcomes.

Apr 20, 2010

Novartis receives US FDA approval for Zortress® (everolimus) to prevent organ rejection in adult kidney transplant recipients

Novartis has received FDA approval for Zortress (everolimus) to prevent organ rejection in adult kidney transplant recipients. This new treatment option allows for reduced doses of cyclosporine, addressing the challenges of organ rejection and side effects in transplant regimens.

Sep 16, 2009

FDA approves Novartis' Valturna for hypertension - PharmaTimes

The FDA has approved Novartis' Valturna, a single-pill combination of Tekturna and Diovan, for treating high blood pressure. This approval is based on a trial showing significant efficacy in lowering hypertension, addressing the needs of patients requiring multiple medications.

Apr 30, 2009

FDA Approves Novartis Pharmaceuticals Corporation's (JOBS) Exforge HCT(R) - the Only High Blood Pressure Treatment to Combine Three Medications in a Single Pill

The FDA has approved Exforge HCT, a unique blood pressure treatment combining three medications in one pill, offering significant efficacy and convenience for patients requiring multiple medications.

Apr 7, 2009

Coartem® receives FDA approval becoming first artemisinin-based combination treatment (ACT) for malaria in the US

Coartem® has received FDA approval as the first artemisinin-based combination treatment for malaria in the US. This highly effective treatment boasts cure rates over 96% and has already saved an estimated 600,000 lives in Africa. It will be available through pharmacies and hospitals in the US.

Jul 31, 2008

Diovan HCT and Exforge approved as first-line therapies in USA - PharmaTimes

The FDA has approved Novartis' Diovan HCT and Exforge as first-line treatments for high blood pressure, supporting guidelines for combination therapy. Clinical trials showed efficacy and tolerability, enhancing physician confidence and patient outcomes. Sales for these products are already strong.

Nov 29, 2007

FDA Approves Novartis Corporation's Diovan(R) for Treatment of High Blood Pressure in Children

The FDA has approved Novartis' Diovan for treating high blood pressure in children aged six to 16. This approval addresses a growing health issue linked to pediatric obesity, providing effective treatment options for this vulnerable group.

Jun 20, 2007

Novartis Corporation's Exforge(R) Receives Final US Approval as New and Powerful Treatment Option for Patients With High Blood Pressure

Novartis' Exforge has received final US approval as a new treatment for high blood pressure, combining valsartan and amlodipine in a single tablet. Supported by extensive clinical trials, it shows significant efficacy in helping patients achieve blood pressure control.

Dec 15, 2006

SkyePharma PLC announces FDA approves FORADIL(R) CERTIHALER(TM)

SkyePharma PLC announced that the FDA has approved FORADIL® CERTIHALER™ for asthma treatment. This approval follows modifications made after a recall due to dosing issues. The product has been approved in 27 countries outside the USA, and SkyePharma is set to earn royalties on sales.

Oct 25, 2006

Novartis Corporation Release: TYZEKA(TM) (telbivudine) Approved By FDA As A New Treatment For Patients With Chronic Hepatitis B

The FDA has approved TYZEKA (telbivudine) for treating chronic hepatitis B, marking a significant achievement for Idenix Pharmaceuticals. The drug shows promising efficacy and safety, with rapid viral suppression in patients. It is expected to be an important treatment option for those affected by the disease.

Jul 28, 2006

Novartis Pharmaceuticals Corporation Release: FDA Approves Supplemental New Drug Application For Antiviral Treatment Famvir(R)

The FDA has approved Famvir as a single-day treatment for recurrent genital herpes and cold sores, demonstrating significant reductions in healing time and symptom resolution, providing new hope for patients.

Jun 27, 2006

FDA Approves Novartis Corporation's Exelon(R) As the First Medication Indicated To Treat Parkinson's Disease Dementia

The FDA has approved Novartis' Exelon as the first medication for treating Parkinson's disease dementia, addressing a significant gap in treatment options. The approval follows a successful large-scale study demonstrating its efficacy in improving patient outcomes.

May 22, 2006

ALZA Corporation Receives FDA Approval For IONSYS(TM) (Fentanyl Iontophoretic Transdermal System)

ALZA Corporation has received FDA approval for IONSYS, a unique fentanyl delivery system for managing acute post-operative pain in hospitalized adults. The device is compact and needle-free, allowing for on-demand dosing. However, it carries risks of respiratory depression and potential for abuse.

Apr 28, 2006

FDA Approves Higher Dose Formulations Of Novartis Pharmaceuticals Corporation's Diovan HCT(R) For Treatment Of High Blood Pressure

The FDA has approved higher dose formulations of Novartis' Diovan HCT for high blood pressure treatment, enhancing dosing options for physicians. The new formulations show significant blood pressure reduction compared to existing therapies, with a comparable safety profile to placebo.

Dec 28, 2005

Novartis Pharmaceuticals Corporation's Femara(R) Receives US Approval As Initial Therapy For Postmenopausal Women With Early Breast Cancer After Surgery

Novartis' Femara has received US approval as an initial therapy for postmenopausal women with hormone-sensitive early breast cancer after surgery. The approval is based on the BIG 1-98 study, which showed significant reductions in the risk of cancer recurrence and spread compared to tamoxifen.

Nov 2, 2005

Novartis Corporation Release: Exjade(R) Receives First Approval Worldwide In The U.S.

Novartis announced the first worldwide approval of Exjade® by the FDA for treating chronic iron overload due to blood transfusions. This once-daily oral iron chelator is expected to improve patient compliance and offers a significant alternative to existing therapies.

Aug 3, 2005

Novartis receives FDA approval for Diovan® (valsartan) to reduce cardiovascular death in heart attack survivors at high risk

Novartis received FDA approval for Diovan® (valsartan) to reduce cardiovascular death in high-risk heart attack survivors. The approval expands its use in heart failure patients and is based on the VALIANT trial, demonstrating improved survival and reduced cardiovascular events.

Oct 29, 2004

TEST#1: Femara® gains U.S. FDA approval as only post-tamoxifen treatment for early breast cancer

Femara® (letrozole) has received FDA approval as the first post-tamoxifen treatment for early breast cancer in postmenopausal women, significantly reducing the risk of recurrence. This approval offers new hope for nearly 100,000 women annually who complete tamoxifen therapy.

May 10, 2001