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Bavarian Nordic Receives U.S. FDA Approval of Jynneos Freeze-Dried Smallpox and Mpox Vaccine

COPENHAGEN, Denmark, March 31, 2025 – Bavarian Nordic A/S (OMX: BAVA) today announced that the U.S. Food and Drug Administration (FDA) has approved...

FDA Approves Qfitlia (fitusiran) to Treat Hemophilia A or B With or Without Inhibitors

Paris, March 28, 2025. The US Food and Drug Administration (FDA) has approved Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine...

FDA Approves Imfinzi (durvalumab) for Muscle Invasive Bladder Cancer

On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment,...

FDA Approves Novartis Radioligand Therapy Pluvicto for Earlier Use Before Chemotherapy in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

Basel, March 28, 2025 – Novartis announced today that the US Food and Drug Administration (FDA) approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan)...

Lawmakers Want School Meal Programs to Allow Whole Milk Again

Whole and 2 percent milk may be coming back to school lunch trays, more than a decade after being removed to help reduce childhood obesity, The Associated...

FDA Approves Qfitlia to Cut Bleeding Episodes in Patients With Hemophilia

The U.S. Food and Drug Administration has approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes...

ACC: Microplastic Exposure Tied to Chronic Disease Prevalence

Microplastic exposure may increase the risk for chronic diseases, according to a study presented at the annual meeting of the American College of Cardiology,...

ACC: Cardiac Arrest Incidence at Long-Distance Races Remains Stable

Despite increased participation in U.S. long-distance running races, cardiac arrest incidence remains stable, according to a study published online March...

ACC: 1999 to 2022 Saw Increase in Maternal Mortality Due to CVD

From 1999 to 2022, there was a considerable increase in maternal mortality due to cardiovascular disease (CVD), according to a study presented at the annual...

Shingles Vaccine Protects Against Dementia

The shingles vaccine can do more than protect seniors from painful, blistering rashes. It also appears to protect older folks from dementia, researchers...

FDA Removes Top Expert on Vaping and Tobacco

The U.S. Food and Drug Administration’s (FDA) top tobacco regulator, Brian King, has been placed on leave as part of a large wave of cuts across...

Zepbound Now Available Through Hims & Hers

The telehealth company Hims & Hers Health is expanding its weight-loss offerings by adding new medications to its platform. The company said Tuesday...

Combination Immunotherapy Shrank a Variety of Metastatic Gastrointestinal Cancers

A new form of tumor infiltrating lymphocyte (TIL) therapy, a form of personalized cancer immunotherapy, dramatically improved the treatment’s effectiveness...

Monthly News Roundup - March 2025

FDA Approves Tremfya for Adults Patients with Active Crohn’s Disease In March, Johnson & Johnson announced the U.S. Food and Drug Administration...

Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti for the Treatments of Acute Bipolar I Disorder and Schizophrenia

Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration...

Otsuka Files Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy

PRINCETON, N.J. and TOKYO, JAPAN March 31, 2025 – Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co.,...

Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer

(BUSINESS WIRE)--Mar. 31, 2025-- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development...

FDA Issues Complete Response Letter for Etripamil for PSVT

MONTREAL and CHARLOTTE, N.C., March 28, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced the U.S....

Sugar Substitute Appears To Boost Appetite, Hunger

Splenda doesn’t directly add calories to your diet, but the sweetener still might lead people to pack on pounds, a new study says. The sugar substitute...

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Latest FDA New Drug Approvals

  • Qfitlia Qfitlia (fitusiran) is an antithrombin-directed small interfering ribonucleic acid for the prophylactic treatment of people with hemophilia...
  • Bomyntra Bomyntra (denosumab-bnht) is a RANK ligand (RANKL) inhibitor biosimilar to Xgeva (denosumab) for use in the prevention of skeletal-related...
  • Conexxence Conexxence (denosumab-bnht) is a RANK ligand (RANKL) inhibitor biosimilar to Prolia (denosumab) used in the treatment of osteoporosis.

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Drugs in Development (Not yet approved)

  • Yutrepia Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil tentatively approved for the treatment of pulmonary arterial...

More drugs in development