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Incyte Announces FDA Approval of Zynyz (retifanlimab-dlwr) Making it the First and Only Approved First-Line Treatment for Advanced Anal Cancer Patients in the United States

(BUSINESS WIRE)--May 15, 2025-- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved...

FDA Grants Accelerated Approval to Emrelis (telisotuzumab vedotin-tllv) for Non-Small Cell Lung Cancer With High c-Met Protein Overexpression

 AbbVie (NYSE: ABBV) today announced that Emrelis (telisotuzumab vedotin-tllv) has been granted accelerated approval by the U.S. Food and Drug...

FDA Approves Merck’s Welireg (belzutifan) for the Treatment of Adults and Pediatric Patients 12 Years and Older With Locally Advanced, Unresectable, or Metastatic Pheochromocytoma or Paraganglioma (PPGL)

(BUSINESS WIRE) May 14, 2025 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration...

Global Phase III Trials Demonstrate That Nerandomilast Slowed Lung Function Decline in IPF and PPF, with Similar Discontinuation Rates to Placebo

Ingelheim, Germany, May 19, 2025 - Boehringer Ingelheim announced today detailed findings from the Phase III FIBRONEER™-IPF and FIBRONEER™-ILD...

Calorie Restrictions, Low-Fat Diets May Reduce Depressive Symptoms

Among adults with elevated cardiometabolic risk, calorie restrictions and low-fat diets may reduce depressive symptoms, according to a review published...

Nicotine Pouch Use in Teens Linked to Lower Risk for Continued Vaping

Nicotine pouch use in adolescence is associated with a lower likelihood of continued vaping, according to a study published online May 19 in Pediatrics.Alyssa...

All-Cause Mortality Higher With Sleep Deprivation in Seniors With Epilepsy

Older adults with sleep deprivation and epilepsy have an elevated risk for all-cause mortality, according to a study published online April 23 in Healthcare. Srikanta...

AAP Updates Guidelines for Pediatric Atopic Dermatitis Management

In a clinical report published online May 19 in Pediatrics, the American Academy of Pediatrics presents updated guidance for the treatment of children...

FDA Launches Postmarket Chemical Review Program to Ensure Food Safety

Last week, the U.S. Food and Drug Administration announced a move to improve transparency and strengthen the safety of chemicals used in the nation's food...

New Models Help Docs Distinguish Severe Pneumonia In Children

MONDAY, May 19, 2025 — New predictive models can accurately distinguish mild, moderate and severe pneumonia in children, helping determine which...

Former President Joe Biden Diagnosed With Aggressive Prostate Cancer

MONDAY, May 19, 2025 — Former President Joe Biden has been diagnosed with advanced prostate cancer that has spread to his bones, his office announced...

Doctors Perform First-Ever Human Bladder Transplant in U.S.

MONDAY, May 19, 2025 — Doctors in Southern California have performed the first human bladder transplant, offering new hope to people with serious...

Apnimed Announces Positive Topline Results in the First Landmark Phase 3 Clinical Trial of AD109, an Investigational Once-Daily Oral Pill for Obstructive Sleep Apnea

CAMBRIDGE, Mass., May 19, 2025 – Apnimed, Inc., a pharmaceutical company building the industry-leading portfolio of first-in-class oral drug candidates...

FDA Drug Safety Communication: FDA Requires Warning About the Risk of Pruritus After Stopping Long-Term Use of Cetirizine or Levocetirizine

FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (Zyrtec, Xyzal,...

Broken Heart Syndrome Remains A Killer, Especially For Men

THURSDAY, May 15, 2025 — “Broken heart syndrome” sounds like a romantic, fairy-tale notion — the idea that suffering a devastating...

FDA Extends PDUFA Date of Biohaven's Troriluzole NDA for Rare Disease Spinocerebellar Ataxia

Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), today announced that the Division of Neurology 1 within FDA's Office of Neuroscience informed the...

FDA Begins Action To Remove Ingestible Fluoride Prescription Drug Products for Children from the Market

The U.S. Food and Drug Administration (FDA) today announced that it is initiating action to remove concentrated ingestible fluoride prescription drug products...

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Latest FDA New Drug Approvals

  • Emrelis Emrelis (telisotuzumab vedotin) is a first-in-class, c-Met protein directed antibody-drug conjugate for the treatment of non-squamous...
  • Avmapki Fakzynja Co-Pack Avmapki Fakzynja Co-Pack (avutometinib and defactinib, co-packaged) is a kinase inhibitor combination for the treatment of KRAS-mutated...
  • Imaavy Imaavy (nipocalimab-aahu) is a neonatal Fc receptor (FcRn) blocker used for the treatment of generalized myasthenia gravis.

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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...

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