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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® –...

Mutation Helps Even Carriers of 'Alzheimer's Gene' Avoid Alzheimer's

A genetic mutation that boosts cell function could protect people against Alzheimer’s disease, even if they carry another gene mutation known to boost...

Another Study Warns of Surgery Risks for Folks Taking Ozempic, Wegovy

People taking weight-loss drugs like Ozempic and Wegovy need to drop them in the days or weeks prior to surgery, a new study warns.Folks on one of these...

CDC Warns of Spike in Bacterial Illness That Can Cause Meningitis

There has been a troubling rise in cases of a rare bacterial illness that can cause meningitis, U.S. health officials warned Thursday.In an alert issued...

U.S. TB Cases Reach Highest Level in a Decade

Tuberculosis cases are on the rise in the United States, with the number of reported infections in 2023 the highest seen in a decade.Forty states logged...

FDA Approves Winrevair for Pulmonary Arterial Hypertension in Adults

The U.S. Food and Drug Administration has approved Winrevair (sotatercept-csrk) as an injectable treatment for pulmonary arterial hypertension (PAH) in...

Rise in Drug-Resistant Gonorrhea in China May Pose Global Threat

Cases of a strain of highly antibiotic-resistant gonorrhea that first emerged in China in 2016 have tripled there in just five years, according to research...

An ED-Based Smoking Cessation Intervention Is Feasible, Effective

A brief opportunistic intervention to support sustained tobacco smoking abstinence in the emergency department is feasible and effective, according to...

Inorganic Nitrate Treatment Cuts Rate of Contrast-Induced Nephropathy

For patients presenting with acute coronary syndromes (ACS) undergoing coronary angiography, inorganic nitrate treatment reduces the rate of contrast-induced...

These 3 Factors Make Your Brain More Vulnerable to Dementia

Out of a host of possible risk factors for dementia, three really stood out in a new analysis: Diabetes, air pollution and alcohol. British and American...

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)...

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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