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Novo Nordisk A/S

$47.09

-1.57 (-3.22%)

A 86Pipeline Score Undervalued Pharma · Commercial
Market Cap
159.69 B
EPS
4.27
P/E Ratio
11.04 $
Value Trade
481.64 M
1.27 %
Week
-5.23 %
1 Month
5.66 %
3 Month
23.35 %
6 Month
10.33 %
5 Year
28,000 %
All Time
Cash Data
  • Cash Position

    -

  • Cash Flow

    Profitable
Overview
Volume
6.33 M
52 Week Range
35.12 - 64.16
% held by Insiders
0.01 %
% held by Institutions
9.88 %
Enterprise Value
218.18 B
Total Shares
3.39 B
Short %
1.01 %
Float Shares
3.37 B
Company Description

locked

Upcoming Catalyst
Catalyst Drug/Treatment Stage Probability of Approval Description Drug Type Therapeutic Area Source
CagriSema Overweight or obesity
NDA

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Peptides
Endocrine System
CagriSema Overweight or obesity
NDA

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Peptides
Endocrine System
CagriSema Overweight or obesity
NDA

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Peptides
Endocrine System
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Catalyst Timeline

Dated clinical, regulatory & corporate events for Novo Nordisk A/S

51Total events
3Upcoming
25Tier-1 (high impact)
2025 – 2027Coverage

Upcoming catalysts 2

TBD
T2Product Launch
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TBD
T1Topline Readout
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Ziltivekimab

Event history 2

TBD
Product LaunchAwiqliApprovedPost-Market
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TBD
Partnership / LicenseCorporate
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Unlock the full Catalyst Timeline
Past FDA Catalysts & PDUFA Decisions
Date Drug Catalyst Stage Outcome Reaction Event Move % Best Trade %
2026-03-26
Awiqli Flextouch (insulin icodec)
PDUFA Date
PDUFA
Approved
2026-03-26
Awiqli Flextouch (insulin icodec)
PDUFA Date
PDUFA
Approved
2026-03-26
Awiqli Flextouch (insulin icodec)
PDUFA Date
PDUFA
Approved
Unlock 14 more historical catalysts
Drug Pipeline Intelligence
A86
Pipeline Score
$215.7B
Pipeline Value
Undervalued
Valuation Signal
166
Drugs Scored
4.5x
rNPV / MCap
Top 98%
Large Pharma
(rank 20 of 933)
Percentile Rank
Novo Nordisk A/S earns an A-grade pipeline score (86/100), with $215.9B risk-adjusted pipeline value, led by Semaglutide J in Diabetes Mellitus, Type 2 (Phase 3).
Showing 1 of 1 assets
DrugIndicationPhaseNCT IDPTRSrNPVStatusEnrollmentVelocityDesignCompletionML SignalLast Change
Semaglutide J
Small molecule
Diabetes Mellitus, Type 2Phase 3NCT0547825266% $17.1B COMPLETED 388 - -Sep 18, 2023 -Dec 12, 2025
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Clinical Trial Results
Drug Name Indications Phase Date Trial Results Summary Title Source
denecimig (Mim8)
hemophilia A
Phase 3
2026-07-11

injection site reactions: children 2.0% of injections, adolescents and adults 1.8% of injections; annualized bleeding rates: adults and adolescents rate 0.75, confidence interval 95% CI 0.60, 0.93, children rate 0.37, confidence interval 95% CI 0.17, 0.76; zero treated bleeds: adults and adolescents 71%, children 89%; participant feedback: easy to use 94.1%, quick to prepare 89.7%

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Novo Nordisk's denecimig (Mim8) demonstrated positive results in long term safety and efficacy in phase 3 hemophilia A FRONTIER extension study at ISTH 2026

Read More
denecimig (Mim8)
hemophilia A
Phase 3
2026-07-11

injection site reactions: children 2.0% of injections, adolescents and adults 1.8% of injections; annualized bleeding rates: adults and adolescents rate 0.75, confidence interval 95% CI 0.60, 0.93, children rate 0.37, confidence interval 95% CI 0.17, 0.76; zero treated bleeds: adults and adolescents 71%, children 89%; participant feedback: easy to use 94.1%, quick to prepare 89.7%

Read More

Novo Nordisk's denecimig (Mim8) demonstrated positive results in long term safety and efficacy in phase 3 hemophilia A FRONTIER extension study at ISTH 2026

Read More
denecimig (Mim8)
hemophilia A
Phase 3
2026-07-11

injection site reactions: children 2.0% of injections, adolescents and adults 1.8% of injections; annualized bleeding rates: adults and adolescents rate 0.75, confidence interval 95% CI 0.60, 0.93, children rate 0.37, confidence interval 95% CI 0.17, 0.76; zero treated bleeds: adults and adolescents 71%, children 89%; participant feedback: easy to use 94.1%, quick to prepare 89.7%

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Novo Nordisk's denecimig (Mim8) demonstrated positive results in long term safety and efficacy in phase 3 hemophilia A FRONTIER extension study at ISTH 2026

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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
NVO 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
2026-11-20 0.00 0 - - - - - -
2026-11-20 0.00 0 - - - - - -
2026-11-20 0.00 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
NVO
Aug 11, 2026
NVOFDA Updates

Novo Nordisk's Awiqli®, the first once-weekly basal insulin for adults with type 2 diabetes, now available in the US

Novo Nordisk has launched Awiqli® (insulin icodec-abae), the first once-weekly basal insulin for adults with type 2 diabetes, following FDA approval. This innovative treatment simplifies insulin therapy by reducing the injection frequency from daily to weekly. Awiqli® is now available at over 70,000 pharmacies across the U.S., with affordability programs for eligible patients.

Read more →
NVO
Aug 10, 2026
NVOGeneral

Novo Nordisk and AWS enter strategic partnership to accelerate drug discovery through AI

Novo Nordisk has partnered with Amazon Web Services (AWS) to enhance drug discovery and modernize its technology infrastructure. This collaboration includes the establishment of a co-innovation hub in London, where teams from both companies will work together using AWS's AI technologies. The partnership aims to improve productivity and reduce the time to market for new medicines.

Read more →
NVO
Aug 5, 2026
NVOGeneral

Novo Nordisk wins Dutch court injunction protecting patients from unapproved, unlawful compounded semaglutide nasal spray

Novo Nordisk secured a preliminary injunction from the District Court of The Hague against Ceban Ziekenhuisfarmacie B.V. for patent infringement regarding a compounded semaglutide nasal spray. The court ruled that Ceban must cease its infringing activities and remove product listings. This ruling emphasizes the importance of protecting patients from unapproved medications and maintaining high standards for pharmaceutical safety and efficacy.

Read more →
NVO
Aug 4, 2026
NVOGeneral
▼ -6.6%on this newsshared move

Novo Nordisk reports adjusted operating profit of DKK 33,389 million for Q2 2026 and raises full-year outlook

Novo Nordisk reported a Q2 2026 adjusted operating profit of DKK 33,389 million, reflecting an 11% increase at CER. The company raised its full-year outlook due to strong GLP-1 product sales, particularly the Wegovy pill, which has seen significant uptake in the US. However, reported operating profit decreased by 16% due to prior rebate provisions and impairment charges.

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NVO
Aug 4, 2026
NVOGeneral
▼ -6.8%on this newsshared move

Novo Nordisk raises adjusted sales and adjusted operating profit outlook for 2026

Novo Nordisk has raised its adjusted sales and operating profit outlook for 2026, following a 7% increase in adjusted sales and an 11% rise in adjusted operating profit for Q2 2026. The improved outlook is primarily attributed to heightened expectations for GLP-1 product sales, despite the overall growth forecast remaining between 0% to -6%. The company will provide a full financial disclosure on August 4, 2026.

Read more →
NVO
Aug 4, 2026
NVOGeneral
▼ -6%on this newsshared move

H1 Partners with Novo Nordisk to Scale AI-Driven Clinical Development

H1 has partnered with Novo Nordisk to enhance clinical development using AI. The collaboration focuses on creating AI-driven workflows and proprietary data to improve clinical trial efficiency. H1 will also acquire rights to StudyHub, an AI-enabled platform developed by Novo Nordisk. This partnership aims to expedite the drug approval process and improve decision-making in clinical trials.

Read more →
NVO
Jul 31, 2026
NVOPhases
▼ -8.8%on this newsshared move

Novo Nordisk provides update on the ZEUS phase 3 trial in people with ASCVD, CKD and inflammation

Novo Nordisk announced results from the ZEUS phase 3 trial, where ziltivekimab showed expected biological effects but failed to reduce major adverse cardiovascular events in patients with ASCVD, CKD, and inflammation. The trial involved over 6,300 participants and indicated similar rates of adverse events compared to placebo. Despite the lack of MACE benefits, Novo Nordisk remains committed to cardiovascular research.

Read more →
NVO
Jul 23, 2026
NVOGeneral

Crux Collaborates with Novo Nordisk to Offer Access to Wegovy® and Other Obesity Management Medications

Crux has partnered with Novo Nordisk to enhance access to anti-obesity medications, including Wegovy®, for employer health plans in the U.S. This collaboration introduces a new pharmacy benefit structure aimed at making these medications more affordable and accessible. The initiative reflects a growing focus on addressing obesity through effective medical solutions.

Read more →
NVO
Jul 21, 2026
NVOGeneral

Novo Nordisk takes action to stop multiple misleading national GLP-1 advertising campaigns by Eli Lilly

Novo Nordisk has filed a lawsuit against Eli Lilly for misleading advertising that compares its medications for obesity and type 2 diabetes. The lawsuit claims that Lilly's ads use outdated studies and omit critical information about Novo Nordisk's products, creating a false impression of superiority. Novo Nordisk seeks a permanent injunction to stop these misleading campaigns and ensure consumers receive accurate information.

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NVO
Jul 20, 2026
NVOGeneral

Fangzhou Launches Novo Nordisk’s Once-Weekly Basal Insulin/GLP-1 Therapy in China

Fangzhou Inc. has launched Kyinsu®, the first once-weekly basal insulin/GLP-1 therapy, in China, enhancing access to innovative diabetes treatments. This therapy combines insulin icodec and semaglutide, aiming to reduce the burden of daily injections for type 2 diabetes patients. Fangzhou's AI-powered platform supports long-term disease management, marking a significant step in diabetes care.

Read more →
NVO
Jul 15, 2026
NVOFDA Updates

Novo Nordisk receives European Commission approval of Wegovy® pill as first oral GLP-1 for weight management in the EU; single, ready-to-use pen for higher dose 7.2 mg also approved

Novo Nordisk has received European Commission approval for Wegovy® pill, the first oral GLP-1 receptor agonist for weight management in the EU. This approval follows a positive opinion from the EMA and is based on the OASIS clinical trial program, which showed significant weight loss results. Additionally, a higher dose injection of Wegovy® has also been approved.

Read more →
NVO
Jul 11, 2026
NVOPhases

Novo Nordisk's denecimig (Mim8) demonstrated positive results in long term safety and efficacy in phase 3 hemophilia A FRONTIER extension study at ISTH 2026

Novo Nordisk presented positive interim data from the phase 3 FRONTIER4 study on denecimig (Mim8), highlighting its long-term safety and efficacy in hemophilia A patients. The study included various dosing regimens and showed a low incidence of injection-site reactions. Notably, a high percentage of participants experienced zero treated bleeds, reinforcing denecimig's potential as a preventive treatment option.

Read more →
NVO
Jul 2, 2026
NVOGeneral

Brenus Pharma stärkt seine Governance durch die Ernennung eines neuen President und die Berufung einer ehemaligen EVP von Novo Nordisk als unabhängiges Mitglied

Brenus Pharma has strengthened its governance by appointing a new President and bringing in a former EVP from Novo Nordisk as an independent board member. This move aims to enhance the company's leadership and oversight. The changes reflect Brenus Pharma's commitment to improving its corporate governance structure.

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NVO
Jul 2, 2026
NVOGeneral

Resumen: Brenus Pharma refuerza su gobierno corporativo con el nombramiento de un nuevo presidente y la incorporación del ex vicepresidente ejecutivo de Novo Nordisk como miembro independiente

Brenus Pharma has strengthened its corporate governance by appointing a new president and adding a former executive vice president of Novo Nordisk as an independent member. This move aims to enhance the company's leadership structure and oversight. The changes reflect Brenus Pharma's commitment to improving its governance practices.

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NVO
Jul 2, 2026
NVOGeneral

Riassunto: Brenus Pharma consolida la propria governance con l'arrivo di un nuovo presidente e la nomina a membro indipendente di un ex EVP di Novo Nordisk

Brenus Pharma has strengthened its governance by appointing a new president and an independent member from Novo Nordisk. This move is expected to enhance the company's leadership and strategic direction. The changes reflect Brenus Pharma's commitment to improving its operational framework.

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NVO
Jul 2, 2026
NVOGeneral

Samenvatting: Brenus Pharma versterkt zijn bestuur met de aanstelling van een nieuwe voorzitter en de benoeming van de voormalige EVP van Novo Nordisk tot onafhankelijk lid

Brenus Pharma has strengthened its board by appointing a new chairman and naming the former EVP of Novo Nordisk as an independent member. This move is aimed at enhancing the company's governance and strategic direction. The changes reflect Brenus Pharma's commitment to leadership and expertise in the biopharma sector.

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NVO
Jul 2, 2026
NVOGeneral

Brenus Pharma Strengthens Its Governance With Designation of a New President and Appointment of Former Novo Nordisk EVP as Independent Member

Brenus Pharma has announced the appointment of a new president and the addition of a former executive vice president from Novo Nordisk as an independent board member. This move is aimed at strengthening the company's governance structure. The changes reflect Brenus Pharma's commitment to enhancing leadership and oversight.

Read more →
NVO
Jun 26, 2026
NVOConferences/Events

Novo Nordisk to showcase new data across its hemophilia portfolio at the ISTH Congress 2026, featuring investigational denecimig

Novo Nordisk will present new data on its hemophilia portfolio at the ISTH Congress 2026, including findings from the FRONTIER4 study on investigational denecimig. The data will cover various dosing frequencies and age groups for hemophilia A patients. Additionally, results from the explorer10 study on concizumab will be shared, focusing on pediatric patients with inhibitors.

Read more →
NVO
Jun 15, 2026
NVOGeneral

Novo Nordisk A/S - share repurchase programme

Novo Nordisk has initiated a share repurchase program, allowing for the buyback of up to DKK 15 billion worth of B shares over a 12-month period. As of June 12, 2026, the company has repurchased nearly 20 million shares, reflecting a proactive approach to enhancing shareholder value. The program is in compliance with European regulations and aims to optimize the company's capital structure.

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NVO
Jun 11, 2026
NVOGeneral

Novo Nordisk A/S: IT Security incident at Novo Nordisk

Novo Nordisk A/S reported an IT security incident involving unauthorized access to some internal systems. The company has initiated an investigation with external cybersecurity experts and is coordinating with authorities. While core operations remain unaffected, some non-public personal data was copied externally. The company is taking measures to secure its systems.

Read more →
NVO
Jun 11, 2026
NVOFDA Updates

Novo Nordisk: Wegovy® pill (semaglutide tablets) becomes first daily GLP-1 weight-loss pill approved in the UK

Novo Nordisk's Wegovy pill, an oral GLP-1 receptor agonist for weight management, has been approved in the UK. This approval is based on the OASIS 4 trial results, showing significant weight loss compared to placebo. The pill offers a daily alternative to injectable treatments for adults living with obesity or overweight. Wegovy is expected to be available via private prescription shortly.

Read more →
NVO
May 26, 2026
NVOGeneral

Novo Nordisk global observational study reveals 2 in 5 people with cardiovascular disease have cardiovascular inflammation, increasing their risk of heart attack and stroke

Novo Nordisk's POSEIDON study reveals that 40% of patients with cardiovascular disease have cardiovascular inflammation, which increases their risk of heart attacks and strokes. The study, involving 18,904 patients across 18 countries, underscores a significant gap in cardiovascular care, as inflammation persists despite standard treatments. These findings highlight the need for targeted therapies to address this unmet need.

Read more →
NVO
May 22, 2026
NVOFDA Updates

Novo Nordisk A/S: Wegovy® pill (oral semaglutide) recommended by CHMP for approval in the EU as the first oral GLP-1 representing the most efficacious oral obesity treatment in its class

Novo Nordisk's Wegovy pill, an oral semaglutide treatment, has received a positive recommendation from the CHMP for approval in the EU. This marks it as the first oral GLP-1 therapy for weight management, demonstrating a mean weight loss of 16.6%. The recommendation includes data showing its effectiveness in reducing cardiovascular risks. The launch is planned for select markets outside the US in late 2026.

Read more →
NVO
May 22, 2026
NVOFDA Updates

Novo Nordisk A/S: CHMP recommends EU approval of Wegovy® 7.2 mg in a single-dose pen, providing up to 20.7% mean weight loss (1)

Novo Nordisk announced that the CHMP has recommended the approval of Wegovy® 7.2 mg in a single-dose pen for obesity treatment in the EU. The drug demonstrated a mean weight loss of 20.7% in the STEP UP trial, with one-third of participants achieving over 25% weight loss. The launch is expected in Q3 2026.

Read more →
NVO
May 19, 2026
NVOConferences/Events

Novo Nordisk to unveil data showing semaglutide tackles the liver disease crisis affecting about 1 in 3 people living with overweight and obesity worldwide

Novo Nordisk is set to present new data on semaglutide at the EASL Congress 2026, demonstrating its effectiveness in treating metabolic dysfunction-associated steatohepatitis (MASH). The findings from the ESSENCE trial confirm semaglutide's favorable liver safety profile and its benefits for various patient subgroups, including menopausal women and Japanese populations. This highlights the urgent need for better treatment options for the largely undiagnosed MASH patient population.

Read more →
NVO
May 12, 2026
NVOGeneral

Novo Nordisk A/S: Trading in Novo Nordisk shares by board members, executives and associated persons

Novo Nordisk has disclosed transactions made in its shares by board members and executives, in compliance with market abuse regulations. This announcement reflects the company's commitment to transparency in financial dealings. The report includes details on aggregated volumes and prices of the transactions, reinforcing Novo Nordisk's dedication to ethical practices.

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NVO
Mar 27, 2026
NVOGeneral

SECURITIES AND EXCHANGE COMMISSION

The article discusses the Articles of Association for Novo Nordisk A/S, detailing the company's name, objects, share capital, share issuance, and governance structure. It outlines the class structures of shares, rights of shareholders, and the procedures for increasing share capital. The document serves as a formal declaration of the company's regulatory compliance and operational guidelines. The provisions also include details about general meetings and shareholder rights.

Read more →
NVO
Mar 26, 2026
NVOFDA Updates

FDA approves Novo Nordisk's Awiqli®, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes

The FDA has approved Awiqli® (insulin icodec-abae), the first once-weekly basal insulin for adults with type 2 diabetes, providing an alternative to daily injections. This approval aims to enhance patient adherence and improve glycemic control.

Read more →
NVO
Mar 19, 2026
NVOFDA Updates

FDA approves Novo Nordisk's new Wegovy® HD injection, delivering the highest weight loss to date for a Wegovy® injection, adding to its already expansive clinical profile

The FDA has approved Novo Nordisk's Wegovy® HD injection, which shows significant weight loss results in adults with obesity. The approval enhances Wegovy's clinical profile, offering a higher dose and additional indications not available with other GLP-1 medications.

Read more →
NVO
Feb 27, 2026
NVOFDA Updates

FDA approves Novo Nordisk's Sogroya® as the first and only once-weekly, long-acting growth hormone for three additional pediatric indications

The FDA has approved Novo Nordisk's Sogroya® as the first once-weekly growth hormone for three additional pediatric indications, enhancing treatment options for children with growth disorders. This approval addresses adherence challenges associated with daily injections and shows non-inferiority to traditional therapies in clinical trials.

Read more →
NVO
Dec 22, 2025
NVOFDA Updates

News Details

Novo Nordisk's Wegovy® pill has been approved by the FDA as the first oral GLP-1 therapy for weight management, showing a mean weight loss of 16.6% in trials. The launch is expected in early January 2026, providing a new treatment option for patients with obesity or overweight.

Read more →
NVO
Aug 15, 2025
NVOFDA Updates

Wegovy® approved by FDA for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis

Wegovy® (semaglutide) has received FDA approval for treating adults with noncirrhotic MASH and moderate to advanced liver fibrosis. The approval is based on positive results from the ESSENCE trial, showing significant improvements in liver health compared to placebo.

Read more →
NVO
Jul 31, 2025
NVOFDA Updates
▼ -5.9%on this news

FDA approves Alhemo® as once-daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes for adults and children 12 years of age and older with hemophilia A or B (HA/HB) without inhibitors

The FDA has approved Alhemo® for once-daily prophylactic treatment to reduce bleeding episodes in hemophilia A or B patients aged 12 and older without inhibitors. The approval is based on phase 3 trial data showing significant reductions in bleeding rates, providing a new subcutaneous treatment option.

Read more →
NVO
Jan 28, 2025
NVOFDA Updates

FDA approves Ozempic® (semaglutide) as the only GLP-1 RA to reduce the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease

The FDA has approved Ozempic® (semaglutide) for reducing the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease, based on positive results from the FLOW trial. This approval highlights the drug's broad indications and addresses a significant health need.

Read more →
NVO
Dec 20, 2024
NVOFDA Updates
▼ -17.8%on this news

FDA approves Alhemo® injection as once-daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes for adults and children 12 years of age and older with hemophilia A or B with inhibitors

The FDA has approved Alhemo® injection for once-daily prophylactic treatment to reduce bleeding episodes in adults and children with hemophilia A or B with inhibitors. The approval is based on a pivotal trial showing an 86% reduction in bleeding episodes, marking a significant advancement in treatment options for this patient population.

Read more →
NVO
Jul 10, 2024
NVOFDA Updates

Novo Nordisk receives Complete Response Letter in the US for once-weekly basal insulin icodec

Novo Nordisk received a Complete Response Letter from the FDA for its once-weekly basal insulin icodec application, citing manufacturing and indication concerns. The company plans to collaborate with the FDA but does not anticipate meeting the requests in 2024.

Read more →
NVO
Sep 29, 2023
NVOFDA Updates

FDA approves Rivfloza™ for children ≥9 years old and adults living with primary hyperoxaluria type 1 (PH1), a rare genetic condition

The FDA has approved Rivfloza™ (nedosiran) for children aged 9 and older and adults with primary hyperoxaluria type 1 (PH1). This RNAi therapy significantly reduces urinary oxalate levels, providing a new treatment option for patients with this rare genetic condition.

Read more →
NVO
Jul 1, 2022
NVOFDA Updates

News details

Novo Nordisk announced the launch of an unbranded biologic of Tresiba, a long-acting insulin, to enhance affordability for diabetes patients. The product will be available at a 65% discount and is part of broader initiatives to support those struggling to afford insulin.

Read more →
NVO
Jun 4, 2021
NVOFDA Updates

Novo Nordisk receives FDA approval for Wegovy™ to treat adults with obesity based on unprecedented efficacy for a prescription medicine in clinical trials

Novo Nordisk's Wegovy™ has received FDA approval as the first prescription weight-loss medication with once-weekly dosing, showing significant efficacy in clinical trials. The approval marks a pivotal moment in obesity treatment, offering a non-surgical option for adults with obesity.

Read more →
NVO
Oct 21, 2019
NVOFDA Updates

FDA approves Fiasp for use in insulin infusion pumps for adults with type 1 or type 2 diabetes

The FDA has approved Fiasp for use in insulin infusion pumps for adults with type 1 or type 2 diabetes, enhancing treatment options. This decision is based on clinical trial data confirming its efficacy and safety, addressing the needs of insulin pump users.

Read more →
NVO
Sep 20, 2019
NVOFDA Updates

FDA approves Rybelsus® (semaglutide), the first GLP-1 analog treatment available in a pill for adults with type 2 diabetes

The FDA has approved Rybelsus® (semaglutide), the first oral GLP-1 analog for adults with type 2 diabetes. This new treatment option aims to improve blood sugar management and is expected to enhance patient adherence compared to injectable therapies.

Read more →
NVO
Dec 5, 2017
NVOFDA Updates

Novo Nordisk Receives FDA Approval of OZEMPIC® (semaglutide) Injection For the Treatment of Adults with Type 2 Diabetes

Novo Nordisk's OZEMPIC® (semaglutide) injection has received FDA approval for treating adults with type 2 diabetes. The drug, administered weekly, showed significant improvements in glycemic control and weight reduction in clinical trials. It will be launched in early 2018, aiming for broad insurance coverage.

Read more →
NVO
Sep 29, 2017
NVOFDA Updates

Novo Nordisk Receives FDA Approval for Fiasp®, a New Fast-Acting Mealtime Insulin

Novo Nordisk has received FDA approval for Fiasp®, a fast-acting mealtime insulin aimed at improving glycemic control in adults with type 1 and type 2 diabetes. Fiasp® can be administered at meal onset and offers a Savings Card program for eligible patients.

Read more →
NVO
Dec 16, 2016
NVOFDA Updates

Novo Nordisk A/S Receives FDA Approval Of Tresiba (Insulin Degludec Injection 100 U/Ml, 200 U/Ml) For Use In Children And Adolescents With Diabetes

Novo Nordisk's Tresiba, a long-acting insulin, has received FDA approval for use in children and adolescents with diabetes, providing a new treatment option to improve glycemic control. The approval is based on positive trial results, highlighting its once-daily dosing and effectiveness.

Read more →
NVO
Nov 21, 2016
NVOFDA Updates

Novo Nordisk receives US FDA approval for Xultophy® 100/3.6

Novo Nordisk has received FDA approval for Xultophy® 100/3.6, a treatment for adults with type 2 diabetes. The drug combines insulin degludec and liraglutide, showing significant improvements in glycaemic control. It will be launched in the US in the first half of 2017.

Read more →
NVO
Sep 25, 2015
NVOFDA Updates

Novo Nordisk Receives FDA Approval for Tresiba® (insulin degludec injection) for Adults with Type 1 and Type 2 Diabetes

Novo Nordisk announced FDA approval for Tresiba® (insulin degludec injection) for adults with type 1 and type 2 diabetes. This long-acting insulin offers flexible dosing and improves glycemic control, marking the first new basal insulin approval in a decade.

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NVO
Dec 23, 2014
NVOFDA Updates

Novo Nordisk receives FDA approval for Saxenda® (liraglutide [rDNA origin] injection) for chronic weight management

Novo Nordisk has received FDA approval for Saxenda® (liraglutide injection), the first once-daily GLP-1 receptor agonist for chronic weight management in adults with obesity or overweight. The drug showed significant weight loss benefits in clinical trials and is expected to launch in the U.S. in 2015.

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NVO
Nov 25, 2009
NVOFDA Updates

FDA Approves Novo Nordisk A/S's 10 mcg Dose of Vagifem(R) for the Treatment of Atrophic Vaginitis Due to Menopause Study Shows Relief of Postmenopausal Symptoms

The FDA has approved Novo Nordisk's 10 mcg dose of Vagifem(R) for treating atrophic vaginitis due to menopause, offering a lower dose option for effective symptom relief in postmenopausal women. The treatment is designed to improve vaginal health with minimal systemic absorption.

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NVO
Oct 19, 2005
NVOFDA Updates

FDA Approves Novo Nordisk's Levemir(R) For Treatment Of Diabetes In Children

The FDA has approved Novo Nordisk's Levemir for treating diabetes in children, marking a significant advancement in diabetes care. Levemir is a long-acting insulin shown to be safe and effective in clinical studies. The company plans to launch the product for both adults and children within eight months.

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NVO
Jun 20, 2000
NVOFDA Updates

US Food and Drug Administration approves liquid Norditropin®

The FDA has approved Novo Nordisk's liquid growth hormone, Norditropin®, which is the first premixed version with a dedicated delivery system. This approval aims to enhance convenience for patients and is expected to benefit children with growth hormone insufficiency.

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