Recent Updates
Recently added Catalysts

Upcoming Catalyst

Drug Pipeline Intelligence

Clinical Trial Results

Inside Trades

Options Data

News Section

Hedge Funds

Ownership Trends

Competitive Position

AstraZeneca PLC

$169.66

+2.95 (+1.77%)

A 86Pipeline Score Fair Value Pharma · Commercial
Market Cap
275.20 B
EPS
6.61
P/E Ratio
25.68 $
Value Trade
605.23 M
5.97 %
Week
0.01 %
1 Month
-9.36 %
3 Month
-17.88 %
6 Month
64.22 %
5 Year
368.75 %
All Time
Cash Data
  • Cash Position

    -

  • Cash Flow

    Profitable
Overview
Volume
3.45 M
52 Week Range
145.79 - 212.71
% held by Insiders
3.43 %
% held by Institutions
61.07 %
Enterprise Value
301.56 B
Total Shares
1.55 B
Short %
0.12 %
Float Shares
1.48 B
Company Description
HQ: Cambridge
Founded:1913
Employees:96,100

locked

Upcoming Catalyst
Catalyst Drug/Treatment Stage Probability of Approval Description Drug Type Therapeutic Area Source
Example Drug Treatment for example condition requiring FDA review
Phase 3
-%

FDA review of the new drug application for the treatment of example condition.

Read More
Small Molecule
Oncology
Example Drug Treatment for example condition requiring FDA review
Phase 3
-%

FDA review of the new drug application for the treatment of example condition.

Read More
Small Molecule
Oncology
Example Drug Treatment for example condition requiring FDA review
Phase 3
-%

FDA review of the new drug application for the treatment of example condition.

Read More
Small Molecule
Oncology
Unlock Upcoming Catalyst data

Catalyst Timeline

Dated clinical, regulatory & corporate events for AstraZeneca PLC

84Total events
8Upcoming
58Tier-1 (high impact)
2024 – 2026Coverage

Upcoming catalysts 2

TBD
T1FDA Filing Accepted
Subscribe to view catalyst details
BREZTRIApproved
TBD
T2Other Regulator Milestone
Subscribe to view catalyst details
KoselugoApproved

Event history 2

TBD
Quarterly UpdateCorporate
Subscribe to view catalyst details
TBD
Partnership / LicenseZegfrovyApprovedCorporate
Subscribe to view catalyst details
Unlock the full Catalyst Timeline
Past FDA Catalysts & PDUFA Decisions
Date Drug Catalyst Stage Outcome Reaction Event Move % Best Trade %
2026-07-07
ENHERTU (fam-trastuzumab deruxtecan-nxki)
PDUFA Date
PDUFA
Approved
2026-07-07
ENHERTU (fam-trastuzumab deruxtecan-nxki)
PDUFA Date
PDUFA
Approved
2026-07-07
ENHERTU (fam-trastuzumab deruxtecan-nxki)
PDUFA Date
PDUFA
Approved
Unlock 14 more historical catalysts
Drug Pipeline Intelligence
A86
Pipeline Score
$187.5B
Pipeline Value
Fair Value
Valuation Signal
633
Drugs Scored
2.3x
rNPV / MCap
Top 98%
Large Pharma
(rank 20 of 933)
Percentile Rank
AstraZeneca PLC earns an A-grade pipeline score (86/100), with $187.6B risk-adjusted pipeline value, led by Exenatide once weekly in Diabetes Mellitus, Type 2 (Phase 3).
Showing 1 of 1 assets
DrugIndicationPhaseNCT IDPTRSrNPVStatusEnrollmentVelocityDesignCompletionML SignalLast Change
Exenatide once weekly
Small molecule
Polycystic Ovary SyndromePhase 3NCT0263538658% $13.6B COMPLETED 119 - -Oct 9, 2020 -Jan 29, 2021
Unlock Drug Pipeline Intelligence
Clinical Trial Results
Drug Name Indications Phase Date Trial Results Summary Title Source
BREZTRI
uncontrolled asthma
Phase 3
2026-02-13

BREZTRI improved lung function by 76mL (95% CI 57-94 mL, unadjusted p<0.001, as measured by morning pre-dose trough FEV1 over 24 weeks); 90mL (95% CI 72-108 mL, unadjusted p<0.001, as measured by FEV1 AUC0-3 over 24 weeks)

Read More

Positive and clinically meaningful results from the Phase III KALOS and LOGOS trials for BREZTRI in patients with uncontrolled asthma published in The Lancet Respiratory Medicine

Read More
BREZTRI
uncontrolled asthma
Phase 3
2026-02-13

BREZTRI improved lung function by 76mL (95% CI 57-94 mL, unadjusted p<0.001, as measured by morning pre-dose trough FEV1 over 24 weeks); 90mL (95% CI 72-108 mL, unadjusted p<0.001, as measured by FEV1 AUC0-3 over 24 weeks)

Read More

Positive and clinically meaningful results from the Phase III KALOS and LOGOS trials for BREZTRI in patients with uncontrolled asthma published in The Lancet Respiratory Medicine

Read More
BREZTRI
uncontrolled asthma
Phase 3
2026-02-13

BREZTRI improved lung function by 76mL (95% CI 57-94 mL, unadjusted p<0.001, as measured by morning pre-dose trough FEV1 over 24 weeks); 90mL (95% CI 72-108 mL, unadjusted p<0.001, as measured by FEV1 AUC0-3 over 24 weeks)

Read More

Positive and clinically meaningful results from the Phase III KALOS and LOGOS trials for BREZTRI in patients with uncontrolled asthma published in The Lancet Respiratory Medicine

Read More
Unlock Clinical Trial Results data
Inside Trades
TREND
CORPORATE INSIDERS BOUGHT SHARES WORTH 1.8M IN THE LAST 3 MONTHS
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLD
INSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Unlock Inside Trades data
Hedge Funds
TREND
HEDGE FUNDS INCREASED HOLDINGS BY 200.0K SHARES IN THE LAST QUARTER
Shares Held
2040.00B1530.00B1020.00B510.00B0
Q3
2024
Q4
2024
Q1
2025
Q2
2025
HEDGE FUNDS
SOLD
HEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Fund Count
60%
Share Volume
25%
Conviction
15%
HedgeFund Name
( 3 )
% of Portfolio Current MV
-
Shares Owned
-
Activity
Avg Price $0

Example Capital Management

2.5 %
15.00 M
250.00 K

Example Capital Management

2.5 %
15.00 M
250.00 K

Example Capital Management

2.5 %
15.00 M
250.00 K
Unlock Hedge Funds table data
AZN Institutional Ownership Trends
Current Insider %
5.20%
+0.00%
Current Institutional %
62.40%
+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
ExpirationVolumeOpen InterestImplied Volatility CallsImplied Volatility Puts
CallsPutsPut-Call RatioCallsPutsPut-Call RatioIVOiWaIvVWaIvIVOiWaIvVWaIv
2026-09-180 0.00 0 0 - - - - - -
2026-09-180 0.00 0 0 - - - - - -
2026-09-180 0.00 0 0 - - - - - -
Unlock Option Chain Statistics data
Option Chain
CallsStrikePuts
Last PriceVolumeOpen InterestLast PriceVolumeOpen Interest
No data available
Unlock Option Chain data
Unlock Options Chart data
Open interest
0 600K 1.2M 1.8M Avg OI 1.00 M Open Interest
0 1 2 3 1.1 Put-Call Ratio
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
0 450K 900K 1.4M Avg OV 750.00 K Option Volume
0 1 2 3 0.95 Put-Call Ratio
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
AZN
Jul 27, 2026
AZNGeneral

AstraZeneca results: H1 and Q2 2026

AstraZeneca reported strong financial results for H1 2026, with total revenue increasing by 9% compared to the previous year. Product sales reached $28.9 billion, reflecting an 8% growth. The company's core EPS also showed a positive trend, rising by 12%. However, collaboration revenue experienced a decline of 6%. Overall, the results indicate a solid performance despite some challenges.

Read more →
AZN
Jul 14, 2026
AZNGeneral

Dizal Announces Global Exclusive License Agreement with AstraZeneca for Zegfrovy

Dizal has entered a global exclusive license agreement with AstraZeneca for Zegfrovy, an EGFR inhibitor for lung cancer. The deal includes a $600M upfront payment and potential milestone payments of up to $900M. Zegfrovy is already approved in China and the US for treating advanced NSCLC with specific mutations. AstraZeneca aims to leverage its oncology expertise to expand Zegfrovy's reach.

Read more →
AZN
Jul 7, 2026
AZNGeneral

Helix Announces Multi-Year Agreement with AstraZeneca to Support Genomic Research for Drug Discovery and Development

Helix has entered a multi-year agreement with AstraZeneca to provide access to its GenoSphere cohorts, which include extensive genomic and clinical data. This collaboration aims to enhance drug discovery and development by leveraging integrated clinico-genomic data. The partnership is expected to accelerate biomedical research and improve the development of targeted therapies.

Read more →
AZN
Jul 2, 2026
AZNPhases
▲ +6.1%on this newsshared move

Abbisko Therapeutics and AstraZeneca Enter a Strategic Collaboration to Conduct the Clinical Trial of Lumipodlin (ABSK043), a First-in-Class Oral PD-L1 Inhibitor, in Combination with TAGRISSO® for NSCLC

Abbisko Therapeutics has partnered with AstraZeneca to conduct a Phase I/II clinical trial for lumipodlin (ABSK043), an oral PD-L1 inhibitor, in combination with TAGRISSO® for treating non-small cell lung cancer (NSCLC). The trial aims to evaluate the safety and efficacy of this novel therapy for patients with EGFR mutations and high PD-L1 expression. The IND application for the study was recently approved by the National Medical Products Administration.

Read more →
AZN
Jun 24, 2026
AZNGeneral

AstraZeneca and YMCA of the USA Announce Landmark Partnership Aimed to Address Gaps in Cancer Care

AstraZeneca has formed a partnership with YMCA of the USA to tackle disparities in cancer care. This collaboration aims to enhance accessibility and improve health outcomes for communities. The initiative is expected to address critical gaps in healthcare services related to cancer treatment and support.

Read more →
AZN
Jun 9, 2026
AZNGeneral

Lung Cancer Research Foundation and AstraZeneca Announce Open Call for Research Proposals with Focus on Small Cell Lung Cancer

The Lung Cancer Research Foundation and AstraZeneca have announced two research awards aimed at improving treatment outcomes for small cell lung cancer (SCLC). The awards, totaling $750,000, will support innovative strategies and patient advocacy efforts. Submissions for research proposals are open until July 15, 2026, with the goal of advancing understanding and treatment of this challenging cancer.

Read more →
AZN
May 28, 2026
AZNGeneral

แอสตร้าเซนเนก้า จับมือ โรช ไดแอกโนสติกส์ เอเชีย แปซิฟิก เร่งสร้างระบบนิเวศด้านพยาธิวิทยาขั้นสูงสำหรับมะเร็งเต้านมและมะเร็งปอด อย่างยั่งยืน แอสตร้าเซนเนก้า และ โรช ไดแอกโนสติกส์ เอเชีย แปซิฟิก ประกาศลงนามบันทึก ความเข้าใจ เพื่อช่วยยกระดับศักยภาพด้านพยาธิวิทยาดิจิทัล...

AstraZeneca has announced the development of an AI-driven companion diagnostic aimed at improving treatment for HER2-positive breast cancer. This innovative technology is designed to enhance predictive accuracy and patient outcomes. The AI system has demonstrated a 60% predictive accuracy, indicating its potential to significantly impact patient care in oncology.

Read more →
AZN
May 22, 2026
AZNFDA Updates

Datroway® Approved in the U.S. as First TROP2 Directed Antibody Drug Conjugate for First-Line Treatment of Patients with Metastatic Triple Negative Breast Cancer Who Are Not PD-1/PD-L1 Inhibitor Candidates

Datroway® has received U.S. approval as the first TROP2 directed antibody drug conjugate. It is intended for first-line treatment of patients with metastatic triple negative breast cancer who are not eligible for PD-1/PD-L1 inhibitors. This approval marks a significant advancement in treatment options for this patient population.

Read more →
AZN
May 21, 2026
AZNGeneral

아스트라제네카, 로슈진단 아시아태평양과 함께 유방암 및 폐암 첨단 병리학의 지속 가능한 생태계 가속화 지원 아스트라제네카(AstraZeneca)와 로슈진단 아시아태평양(Roche Diagnostics Asia Pacific)이 아시아 9개 국가의 디지털 병리 역량 강화 및 암 치료 수준 향상을 위한 3년 업무협약(MOU)를 체결했다고 5월 18일 발표했다. 이는 아시아...

AstraZeneca and Roche Diagnostics Asia Pacific have signed a three-year memorandum of understanding to enhance AI-driven diagnostic capabilities. This partnership aims to improve patient outcomes by integrating advanced computational pathology and AI technologies. The collaboration focuses on developing innovative diagnostic solutions for cancer treatment, particularly targeting HER2 and TROP2 biomarkers.

Read more →
AZN
May 20, 2026
AZNGeneral

स्तन तथा फेफड़ों के कैंसर में एडवांस पैथोलॉजी के लिए एक स्थायी इकोसिस्टम को गति देने में सहायता करने के लिए AstraZeneca ने Roche Diagnostics Asia Pacific के साथ सहयोग किया AstraZeneca और Roche Diagnostics Asia Pacific ने आज नौ एशियाई बाजारों में डिजिटल पैथोलॉजी क्षमताओं को आगे बढ़ाने और कैंसर देखभाल को बेहतर बनाने में...

AstraZeneca has partnered with Roche Diagnostics Asia Pacific to enhance digital pathology capabilities for cancer diagnostics. This collaboration aims to leverage AI technology to improve patient outcomes and diagnostic accuracy. The initiative is expected to significantly benefit the healthcare landscape in Asia Pacific, particularly in the management of cancer treatments.

Read more →
AZN
May 18, 2026
AZNGeneral

AstraZeneca Collaborates with Roche Diagnostics Asia Pacific to Help Accelerate Sustainable Ecosystem for Advanced Pathology in Breast and Lung Cancer AstraZeneca and Roche Diagnostics Asia Pacific today announced a three-year Memorandum of Understanding to help advance digital pathology...

AstraZeneca and Roche Diagnostics Asia Pacific have entered a three-year Memorandum of Understanding to enhance digital pathology capabilities across nine Asian markets. This collaboration aims to improve biomarker testing for breast and lung cancer through AI-powered solutions and educational initiatives. The partnership addresses significant gaps in diagnostic processes and aims to standardize and improve cancer care.

Read more →
AZN
May 15, 2026
AZNFDA Updates

FDA approves AstraZeneca’s new kind of hypertension drug

The FDA has approved AstraZeneca's Baxfendy, a novel hypertension treatment expected to generate over $5 billion annually. The drug, which targets a root cause of hypertension, shows promise in clinical trials and is anticipated to launch soon, although it poses competitive challenges for other biotech firms.

Read more →
AZN
May 1, 2026
AZNFDA Updates

TRUQAP® (capivasertib) recommended by FDA Advisory Committee for PTEN-deficient metastatic hormone-sensitive prostate cancer

The FDA's Oncologic Drugs Advisory Committee has recommended AstraZeneca's TRUQAP (capivasertib) in combination with abiraterone and ADT for PTEN-deficient metastatic hormone-sensitive prostate cancer. This recommendation is based on favorable results from the CAPItello-281 Phase III trial, which demonstrated a significant reduction in disease progression. The treatment addresses a critical need for patients with limited options and is the first targeted therapy for this cancer subtype.

Read more →
AZN
Mar 9, 2026
AZNFDA Updates

ENHERTU® Granted Priority Review in the U.S. as Post-Neoadjuvant Treatment for Patients with HER2 Positive Early Breast Cancer

AstraZeneca and Daiichi Sankyo's ENHERTU has received Priority Review from the FDA for treating HER2 positive early breast cancer patients with residual disease after neoadjuvant therapy. The decision follows promising results from the DESTINY-Breast05 trial, which demonstrated a significant reduction in disease recurrence. The FDA's target action date for this application is July 7, 2026.

Read more →
AZN
Mar 9, 2026
AZNFDA Updates

Koselugo approved in Canada for plexiform neurofibromas in adults with neurofibromatosis type 1

Koselugo (selumetinib) has been approved in Canada for adults with neurofibromatosis type 1 (NF1) suffering from symptomatic, inoperable plexiform neurofibromas. This approval follows positive results from the KOMET Phase III trial, which showed a 20% objective response rate in tumor size reduction. Experts highlight the significance of this treatment option for patients who previously had limited therapeutic choices.

Read more →
AZN
Feb 24, 2026
AZNGeneral

SECURITIES AND EXCHANGE COMMISSION

AstraZeneca PLC has filed a report with the SEC for February 2026, according to the requirements set forth by the Securities Exchange Act of 1934. The filing includes details about the registrant’s annual financial report and compliance with various regulatory requirements. This follows standard practice for foreign issuers under SEC regulations.

Read more →
AZN
Feb 20, 2026
AZNFDA Updates

CALQUENCE® plus venetoclax approved in the US as first all-oral, fixed-duration combination for patients with chronic lymphocytic leukemia in the 1st-line setting

AstraZeneca's CALQUENCE in combination with venetoclax has received FDA approval as the first all-oral, fixed-duration treatment for chronic lymphocytic leukemia (CLL) in adults. This regimen, based on positive AMPLIFY Phase III trial results, offers a highly effective and well-tolerated option for patients. The treatment showed a 77% progression-free rate at three years, significantly outperforming standard chemotherapy. However, it carries risks of serious infections and other adverse effects.

Read more →
AZN
Feb 13, 2026
AZNPhases

Positive and clinically meaningful results from the Phase III KALOS and LOGOS trials for BREZTRI in patients with uncontrolled asthma published in The Lancet Respiratory Medicine

The Phase III KALOS and LOGOS trials demonstrated that AstraZeneca's BREZTRI significantly improved lung function in patients with uncontrolled asthma compared to standard therapies. The results, published in The Lancet Respiratory Medicine, indicate that BREZTRI also reduced the rate of severe asthma exacerbations. The therapy combines an inhaled corticosteroid, a long-acting beta-agonist, and a long-acting muscarinic antagonist.

Read more →
AZN
Feb 12, 2026
AZNGeneral

AstraZeneca awards $3.4 million for programs to improve access to healthcare for patients across the US

AstraZeneca has awarded $3.4 million through its ACT on Health Equity initiative to support nonprofit organizations in the US. This funding will enhance healthcare access and address social barriers faced by underserved communities. The initiative has now contributed over $18 million to various health equity programs, focusing on nutrition and lung health among other areas.

Read more →
AZN
Feb 3, 2026
AZNFDA Updates

DATROWAY® (datopotamab deruxtecan-dlnk) granted Priority Review in the US as 1st-line treatment for patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy

AstraZeneca and Daiichi Sankyo's DATROWAY (datopotamab deruxtecan-dlnk) has received Priority Review from the FDA for treating metastatic triple-negative breast cancer (TNBC) in patients not eligible for immunotherapy. This designation highlights the drug's potential to significantly improve overall survival compared to existing chemotherapy options. The FDA's decision is expected by the second quarter of 2026.

Read more →
AZN
Feb 3, 2026
AZNFDA Updates

DATROWAY® Granted Priority Review in the U.S. as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who Are Not Candidates for Immunotherapy

Daiichi Sankyo and AstraZeneca's DATROWAY has received Priority Review from the FDA for treating metastatic triple negative breast cancer (TNBC) patients who cannot undergo immunotherapy. The application is based on promising results from the TROPION-Breast02 trial, showing improved overall survival and reduced disease progression compared to chemotherapy. The FDA's decision is expected by June 2, 2026.

Read more →
AZN
Feb 3, 2026
AZNFDA Updates

Update on US regulatory review of Saphnelo subcutaneous administration in systemic lupus erythematosus

The FDA issued a complete response letter for AstraZeneca's BLA for Saphnelo's subcutaneous administration in SLE. AstraZeneca is addressing the FDA's concerns and expects a decision in 2026. Saphnelo IV remains available, and it has been approved in the EU for subcutaneous use.

Read more →
AZN
Jan 19, 2026
AZNFDA Updates

ENHERTU® Plus Pertuzumab Type II Variation Application Validated in the EU as First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer

The European Medicines Agency has validated the Type II Variation application for ENHERTU in combination with pertuzumab as a first-line treatment for HER2 positive metastatic breast cancer. This validation initiates the EMA's scientific review process, following promising results from the DESTINY-Breast09 phase 3 trial. The treatment aims to improve outcomes for patients who have had limited options for over a decade.

Read more →
AZN
Jan 13, 2026
AZNPhases

TROPION-Lung17 TROP2 Biomarker Directed Phase 3 Trial of DATROWAY® Initiated in Patients with Previously Treated Advanced Nonsquamous Non-Small Cell Lung Cancer

The TROPION-Lung17 Phase 3 trial has commenced, evaluating DATROWAY in patients with advanced nonsquamous NSCLC. This trial aims to compare DATROWAY to docetaxel in TROP2 NMR positive patients previously treated with immunotherapy and platinum-based chemotherapy. The study is significant as it is the first to prospectively enroll patients based on a TROP2 biomarker, potentially improving treatment outcomes.

Read more →
AZN
Dec 22, 2025
AZNPhases

DESTINY-Endometrial02 Phase 3 Trial of ENHERTU® Initiated as Adjuvant Therapy in Patients with HER2 Expressing Endometrial Cancer

The DESTINY-Endometrial02 Phase 3 trial has commenced, evaluating ENHERTU as an adjuvant therapy for patients with HER2 expressing endometrial cancer. This trial aims to compare ENHERTU with standard chemotherapy treatments. The study is a collaboration involving multiple organizations and seeks to address the lack of approved HER2 directed therapies in this setting. The trial will enroll around 710 patients across various continents.

Read more →
AZN
Dec 22, 2025
AZNFDA Updates

ENHERTU® Granted Breakthrough Therapy Designation in the U.S. as Post-Neoadjuvant Therapy for Patients with HER2 Positive Early Breast Cancer

ENHERTU (trastuzumab deruxtecan) has been awarded Breakthrough Therapy Designation by the FDA for treating adult patients with HER2 positive early breast cancer who have residual disease after neoadjuvant therapy. This designation is based on promising results from the DESTINY-Breast05 phase 3 trial, which demonstrated ENHERTU's potential to improve disease-free survival. The drug has now received a total of ten BTDs, highlighting its significant role in breast cancer treatment.

Read more →
AZN
Nov 3, 2025
AZNGeneral

No. 2723534 THE COMPANIES ACT 2006 PUBLIC COMPANY LIMITED BY SHARES ARTICLES OF ASSOCIATION OF ASTRAZENECA PLC Incorporated 17 June 1992 Registered Office: 1 Francis Crick Avenue Cambridge Biomedical Campus Cambridge CB2

AstraZeneca PLC has published its Articles of Association as part of the compliance with the Companies Act 2006. The document outlines the company's capital structure, rights attached to shares, and governance procedures, including details for general meetings and share transfers. This publication represents a formal update but does not indicate any immediate changes to shareholders' rights or company operations.

Read more →
AZN
Oct 17, 2025
AZNFDA Updates

US FDA Approves Tezspire in CRSwNP, 20 October 2025 07:05 | RNS News | AZN - ASTRAZENECA PLC

The FDA has approved Tezspire for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in patients aged 12 and older, following positive Phase III trial results. This approval expands treatment options for a condition affecting approximately 320 million people globally.

Read more →
AZN
Jun 6, 2025
AZNGeneral

EARLY CHRONIC KIDNEY DISEASE (CKD) INTERVENTION COULD SAVE AUSTRALIA $1 BILLION A YEAR[1] New modelling highlights the potential societal, economic and environmental benefits of early chronic kidney disease (CKD) intervention which could...

AstraZeneca's IMPACT CKD modelling indicates that early intervention in chronic kidney disease (CKD) could save Australia $25.2 billion over 25 years. The model predicts a significant reduction in dialysis demand and improved health outcomes, including decreased cardiovascular events and mortality rates. Additionally, early action could enhance workforce participation and deliver environmental benefits.

Read more →
AZN
Feb 28, 2025
AZNFDA Updates

FDA Approves Expanded Use of Eculizumab (Soliris) for Pediatric Myasthenia Gravis, Bringing New Treatment Options for Children

The FDA has approved the expanded use of eculizumab (Soliris) for pediatric patients with generalized myasthenia gravis, marking a significant advancement in treatment options for children. This approval provides hope for families and is supported by clinical trial data, although the treatment has specific contraindications.

Read more →
AZN
Sep 24, 2024
AZNGeneral

Get To Know Severe Asthma: The Chronic, Life-Threatening Condition Affecting 7-11% Adults In Asian Countries Asthma is well-known as a common respiratory condition. But did you know that there exists a life-threatening type of the condition called severe...

Severe asthma, affecting 7-11% of adults in Asian countries, requires specialized treatment due to its life-threatening nature. Early diagnosis is crucial for effective management, and dedicated clinics offer multidisciplinary care. Symptoms can be unpredictable and challenging to control, necessitating tailored treatment plans, including biologics. Patients are encouraged to monitor their condition closely.

Read more →
AZN
Dec 28, 2023
AZNFDA Updates

Consulta Pública avalia incorporação de nova opção de tratamento no SUS para pacientes com HPN, doença ultra rara e grave AstraZeneca – A Hemoglobinúria Paroxística Noturna (HPN) é um dos cerca de 7 mil tipos de doenças raras existentes no mundo4, e sua gravidade...

AstraZeneca's new treatment for Paroxysmal Nocturnal Hemoglobinuria (PNH) has been approved by ANVISA. This treatment enhances patient quality of life by reducing fatigue and the risk of thrombosis while requiring fewer infusions. A public consultation is currently open to evaluate its incorporation into the Unified Health System (SUS) until January 15, 2024.

Read more →
AZN
Dec 6, 2023
AZNFDA Updates

Koselugo now available in Malaysia for paediatric patients with symptomatic neurofibromatosis type 1 (NF1) plexiform neurofibromas AstraZeneca's Koselugo (selumetinib) is now available in Malaysia as a monotherapy for the treatment of paediatric patients three years of age and...

AstraZeneca's Koselugo (selumetinib) has been approved in Malaysia for pediatric patients aged three and older with symptomatic neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas. This approval aims to address the significant unmet medical needs of NF1 patients, providing them with a much-needed treatment option. The drug has shown promising results in clinical trials, with a confirmed partial response rate of 70%.

Read more →
AZN
Jul 17, 2023
AZNFDA Updates

Press Release: FDA approves Beyfortus™ (nirsevimab-alip) to protect infants against RSV disease

The FDA has approved Beyfortus™ (nirsevimab-alip) for protecting infants against RSV disease, marking a significant advancement in infant health. This monoclonal antibody shows high efficacy and a favorable safety profile, with plans for availability ahead of the 2023-2024 RSV season.

Read more →
AZN
Jul 23, 2020
AZNFDA Updates

AstraZeneca Wins FDA Approval for COPD Treatment

AstraZeneca received FDA approval for Breztri Aerosphere, a triple-therapy for COPD, based on positive Phase III trial results. The treatment showed significant efficacy compared to dual therapies, offering a new option for patients with this debilitating condition.

Read more →
AZN
Dec 27, 2019
AZNFDA Updates

AstraZeneca and Merck’s Lynparza drug approved by US FDA for pancreatic cancer

AstraZeneca's Lynparza has been approved by the FDA as a first-line maintenance treatment for certain pancreatic cancer patients, following positive Phase III trial results. This approval marks a significant advancement in treatment options for a disease with historically poor outcomes.

Read more →
AZN
Nov 21, 2019
AZNFDA Updates

Calquence OK boosts AstraZeneca's challenge to Imbruvica

AstraZeneca's Calquence has received FDA approval for chronic lymphocytic leukemia, positioning it to compete with AbbVie and Johnson & Johnson's Imbruvica. Analysts predict significant sales growth due to its competitive efficacy and lower side effects.

Read more →
AZN
Oct 1, 2019
AZNFDA Updates

Update on US regulatory review of PT010 in COPD

AstraZeneca announced that the FDA issued a complete response letter for the NDA of PT010, a COPD treatment. The company plans to collaborate with the FDA and submit recent positive trial results. PT010 is already approved in Japan and under review in China and the EU.

Read more →
AZN
May 18, 2018
AZNFDA Updates

AstraZeneca finally gets US Lokelma approval

AstraZeneca's Lokelma has received FDA approval for treating hyperkalemia in adults, based on successful clinical trials. The drug offers rapid normalization of potassium levels, addressing a significant clinical need for patients with chronic kidney disease and heart failure.

Read more →
AZN
Nov 14, 2017
AZNFDA Updates

FASENRA (benralizumab) Receives US FDA Approval For Severe Eosinophilic Asthma

AstraZeneca's FASENRA (benralizumab) has received FDA approval for severe eosinophilic asthma treatment in patients aged 12 and older. The approval is based on positive trial results showing significant reductions in exacerbation rates and improvements in lung function.

Read more →
AZN
Oct 31, 2017
AZNFDA Updates

US FDA APPROVES ASTRAZENECA'S CALQUENCE® (acalabrutinib) FOR ADULT PATIENTS WITH PREVIOUSLY-TREATED MANTLE CELL LYMPHOMA

The FDA has approved AstraZeneca's CALQUENCE (acalabrutinib) for adult patients with previously-treated mantle cell lymphoma, marking a significant advancement in treatment options. The approval is based on promising clinical trial results, although continued approval depends on further verification of clinical benefits.

Read more →
AZN
Jun 23, 2017
AZNFDA Updates

U.S. FDA Approves Bevyxxa® (betrixaban) First and Only Anticoagulant for Hospital and Extended Duration Prevention of Venous Thromboembolism (VTE) in Acutely Ill Medical Patients

The FDA has approved Bevyxxa (betrixaban), the first anticoagulant for hospital and extended duration prevention of venous thromboembolism in acutely ill medical patients. This approval is based on the pivotal Phase 3 APEX Study, demonstrating reduced VTE incidence without significant bleeding risks.

Read more →
AZN
Mar 17, 2017
AZNFDA Updates

AstraZeneca receives Complete Response Letter from US FDA for ZS-9 (sodium zirconium cyclosilicate) for hyperkalaemia

AstraZeneca announced it received a Complete Response Letter from the FDA regarding its New Drug Application for ZS-9, a treatment for hyperkalaemia. The letter does not require new clinical data, and AstraZeneca is committed to resolving the issues with the FDA.

Read more →
AZN
May 27, 2016
AZNFDA Updates

AstraZeneca receives Complete Response Letter from US FDA for sodium zirconium cyclosilicate (ZS-9) for oral suspension for treatment of hyperkalaemia

AstraZeneca announced it received a Complete Response Letter from the FDA regarding its NDA for sodium zirconium cyclosilicate (ZS-9) for hyperkalaemia treatment, citing manufacturing inspection observations. The company is evaluating the CRL and remains committed to the drug's development.

Read more →
AZN
Apr 25, 2016
AZNFDA Updates

AstraZeneca PLC Announces Bevespi Aerosphere(TM) Approved by the US FDA for Patients With COPD

AstraZeneca announced FDA approval for Bevespi Aerosphere, a dual bronchodilator for COPD treatment. It shows superior lung function improvement compared to mono-components and placebo, utilizing AstraZeneca's Co-Suspension Technology. This marks a significant advancement in COPD management.

Read more →
AZN
Nov 13, 2015
AZNFDA Updates

AstraZeneca PLC Release: TAGRISSO (osimertinib) (AZD9291) Approved By The US FDA As Treatment For Patients With EGFR T790M Mutation-Positive Metastatic Non-Small Cell Lung Cancer

AstraZeneca's TAGRISSO (osimertinib) has been approved by the FDA for treating patients with EGFR T790M mutation-positive metastatic non-small cell lung cancer, offering a new option for those who have progressed on previous therapies.

Read more →
AZN
Sep 23, 2011
AZNFDA Updates

FDA Approves Soliris for Rare Pediatric Blood Disorder

The FDA has approved Soliris for treating atypical Hemolytic Uremic Syndrome (aHUS) in pediatric patients, marking the first approved treatment for this rare disease. The approval highlights the drug's effectiveness in improving kidney function and other health metrics, despite potential side effects.

Read more →
AZN
Jul 20, 2011
AZNFDA Updates

FDA Approves AstraZeneca PLC Heart Drug Brilinta

The FDA has approved AstraZeneca's heart drug BRILINTA, indicated for reducing thrombotic cardiovascular events in ACS patients. The approval is based on the PLATO study, showing BRILINTA's effectiveness compared to clopidogrel. AstraZeneca will work on making the drug available to patients while ensuring awareness of its risks.

Read more →
AZN
Apr 29, 2011
AZNFDA Updates

FDA Approves AstraZeneca PLC's NEXIUM(R) I.V. for the Treatment of Gastroesophageal Reflux Disease with Erosive Esophagitis in Pediatric and Adolescent Patients

The FDA has approved AstraZeneca's NEXIUM I.V. for treating gastroesophageal reflux disease with erosive esophagitis in pediatric patients aged 1 month to 17 years, providing a new treatment option for this condition, particularly in infants.

Read more →
AZN
Nov 5, 2010
AZNFDA Updates

Bristol-Myers Squibb Company, AstraZeneca PLC's KOMBIGLYZE(TM) XR (Saxagliptin and Metformin HCl Extended-Release) Tablets, a New Treatment for Type 2 Diabetes Mellitus in Adults, Now Available in U.S. Pharmacies

Bristol-Myers Squibb and AstraZeneca announced that KOMBIGLYZE™ XR, a new treatment for Type 2 Diabetes Mellitus, is now available in U.S. pharmacies following FDA approval. It is the first once-a-day metformin extended-release plus DPP-4 inhibitor combination tablet.

Read more →
AZN
Sep 9, 2010
AZNFDA Updates

FDA Approves New Dosing for FASLODEX® (fulvestrant) Injection in Treatment of Metastatic Breast Cancer in HR+ Postmenopausal Women

The FDA has approved a new 500mg dose of FASLODEX for treating hormone receptor-positive metastatic breast cancer in postmenopausal women, showing improved progression-free survival compared to the 250mg dose. This approval is seen as a significant advancement in treatment options.

Read more →
AZN
Feb 8, 2010
AZNFDA Updates

AstraZeneca's Crestor treatment receives FDA approval for new indication

AstraZeneca's CRESTOR has received FDA approval for a new indication to reduce the risk of stroke, heart attack, and arterial revascularization in individuals at increased risk of cardiovascular disease. This approval is based on the JUPITER study, which demonstrated significant reductions in major cardiovascular events.

Read more →
AZN
Feb 27, 2008
AZNFDA Updates

FDA Approves AstraZeneca PLC's NEXIUM(R) for the Treatment of Short-Term GERD in Children 1 to 11 Years Old

The FDA has approved AstraZeneca's NEXIUM for treating short-term GERD in children aged 1 to 11, introducing a new 10 mg dose formulation. This approval enhances treatment options for pediatric patients and addresses the rising incidence of GERD in children.

Read more →
AZN
Oct 20, 2006
AZNFDA Updates

AstraZeneca PLC Wins FDA Approval For Liquid Nexium

AstraZeneca has received FDA approval for NEXIUM For Delayed-Release Oral Suspension, offering an alternative for patients who struggle with solid pills. The new formulation will be available in early 2007, enhancing treatment options for acid-related diseases.

Read more →
AZN
Mar 31, 2005
AZNFDA Updates

FDA approves Nexium IV - PharmaTimes

The FDA has approved an intravenous version of AstraZeneca's Nexium for short-term treatment of gastroesophageal reflux disease in patients unable to take capsules. This approval is expected to boost sales, despite ongoing lawsuits against the company.

Read more →
Competitive Position
How AZN ranks across every disease it competes in
Competitive Position is a premium feature
See how AZN ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
Start free trial