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FDA Approves Winrevair (sotatercept-csrk) a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension

(BUSINESS WIRE) March 26, 2024 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and...

FDA Approves Medexus's Supplemental Biologics License Application for Ixinity to Treat Hemophilia B in Pediatric Patients

March 26, 2024 - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced that the US Food and Drug Administration (FDA) recently approved Medexus's...

Ultomiris Approved in the US for the Treatment of Adults with Neuromyelitis Optica Spectrum Disorder (NMOSD)

Ultomiris (ravulizumab-cwvz) has been approved in the United States (US) as the first and only long-acting C5 complement inhibitor for the treatment of...

FDA Approves Duvyzat (givinostat) for Duchenne Muscular Dystrophy

(BUSINESS WIRE)-- Mar 22, 2024 -- Italfarmaco S.p.A. announced today that the U.S. Food and Drug Administration (FDA) has approved Duvyzat™ (givinostat),...

FDA Approves Opsynvi (macitentan and tadalafil) for Adults with Pulmonary Arterial Hypertension

RARITAN, NJ, March 22, 2024 – Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Opsynvi® –...

U.S. Mpox Cases Rising Again as Vaccinations Lag

Mpox cases are climbing again in the United States, with the number of reported infections now twice as high as they were at this time last year, new government...

Binge Drinking Boosts Heart Risks, Especially for Women

Imbibing more than a drink per day significantly raises heart risks for all, but binge drinking is especially harmful, particularly for women, new research...

Too Often, Nearby Defibrillators Go Unused on People in Cardiac Arrest

There's been a big push over the past few years to get automated external defibrillators (AEDs) installed in public spaces, to help save lives threatened...

Stressed? Some Genes Could Raise Your Heart Attack Risk

Folks with genetically-driven stress are more likely to suffer heart attacks after nerve-wracking events or times of unrest, a new study shows.People with...

Artificial Intelligence Feasible for Localizing Acute Stroke Lesions

Large language models (LLMs) such as Generative Pretrained Transformers (GPTs) can potentially localize acute stroke lesions, according to a study published...

ACC: Short Sleep Duration Linked to Risk of Developing Hypertension

Short sleep duration is associated with an increased risk of developing hypertension, according to a study scheduled for presentation at the annual meeting...

Supervised Exercise Improves Patient-Reported Outcomes for Metastatic Breast Cancer

Supervised exercise during palliative treatment leads to beneficial effects on fatigue and health-related quality of life (HRQoL) among patients with metastatic...

Timing of Pubertal Development Tied to Adult Cardiometabolic Risk

Pubertal development and its timing may be an important pathway through which early-life exposures shape adulthood cardiometabolic health and disease,...

FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects

The U.S. Food and Drug Administration is warning consumers not to use certain over-the-counter analgesic (pain relief) products that are marketed for topical...

Johnson & Johnson's Nipocalimab Granted U.S. FDA Fast Track Designation to Reduce the Risk of Fetal Neonatal Alloimmune Thrombocytopenia (FNAIT) in Alloimmunized Pregnant Adults

SPRING HOUSE, Pa. March 26, 2024 – Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track...

Tonix Pharmaceuticals Receives Rare Pediatric Disease Designation from the FDA for TNX-2900 for the Treatment of Prader-Willi Syndrome

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development...

Regeneron Provides Update on Biologics License Application for Odronextamab

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued Complete Response Letters (CRLs)...

Can You Build Muscle in Old Age? Yes, and an Expert Has Tips

If you're in your 60s, 70s or even older, you might think your days of productively pumping iron are behind you. That's just not true, said Dr. Adil...

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Recently added consumer and prescribing information: Winrevair, Pemgarda, Tryvio, Edurant and Edurant Ped, Tevimbra, Rezdiffra, Tyenne, Wyost, Letybo, Simlandi

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Latest FDA New Drug Approvals

  • Winrevair Winrevair (sotatercept) is an activin signaling inhibitor used for the treatment of adults with pulmonary arterial hypertension.
  • Duvyzat Duvyzat (givinostat) is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy in patients 6 years of...
  • Opsynvi Opsynvi (macitentan and tadalafil) is a single tablet combination of the endothelin receptor antagonist (ERA) macitentan and the...

More FDA approvals

Drugs in Development (Not yet approved)

  • Yutrepia Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil for the treatment of pulmonary arterial hypertension (PAH) to...
  • Libervant Libervant (diazepam) is a buccal film formulation of the approved benzodiazepine diazepam in development for the management of seizure clusters.

More drugs in development