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FDA Approves Lenmeldy (atidarsagene autotemcel) for Children with Metachromatic Leukodystrophy

TOKYO and LONDON and BOSTON, March 18, 2024 (GLOBE NEWSWIRE) -- Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the...

Xhance Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps

Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the...

FDA Grants Accelerated Approval for Rezdiffra (resmetirom) for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH)

Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH),...

FDA Approves Tevimbra (tislelizumab-jsgr) for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma

(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration...

Positive Results from Phase 3 BouNDless Trial of Investigational ND0612 in People with Parkinson's Disease Experiencing Motor Fluctuation

JERSEY CITY, N.J., March 18, 2024. Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the publication of results in The Lancet Neurology from...

FDA Approves First CAR T-Cell Therapy for Adults With Leukemia or Lymphoma

The U.S. Food and Drug Administration has approved Breyanzi (lisocabtagene maraleucel [liso-cel]) as the first CD19-directed chimeric antigen receptor...

Childhood Lead Exposure Widespread in Chicago

Childhood lead exposure is widespread in Chicago and there are racial inequities evident in testing rates and exposure levels, according to a study published...

Repurposed Drug Fenoprofen Shows Promise Against Endometriosis-Related Pain in Animal Model

Fenoprofen, a nonsteroidal anti-inflammatory drug (NSAID), successfully alleviated pain and inflammation in a rodent model of endometriosis, according...

EPA Issues Final Rule Banning Asbestos

The last remnants of asbestos use in the United States have now been banned by the Environmental Protection Agency. While the known carcinogen has already...

In-Person, Remote Cognitive Behavioral Therapy Similarly Effective

There is little to no difference in the effectiveness of in-person versus therapist-guided remote cognitive behavioral therapy (CBT) across a range of...

Studies Explore Anomalous Health Incidents Reported by Government Personnel

Some U.S. government personnel have reported dizziness, pain, visual problems, and cognitive dysfunction after experiencing intrusive sounds and head pressure,...

Average Middle-Aged American Is Lonelier Than European Peers

Middle-aged Americans are lonelier than ever, with new research showing they are even more isolated than some of their peers in Europe. That does not...

Measles Outbreaks Have CDC Tweaking Travel Guidelines

As millions of Americans prepare to travel abroad this summer and measles outbreaks increase worldwide, the U.S. Centers for Disease Control and Prevention...

Weed Plus Cigarettes Takes Toll on High Schoolers' Grades

High school students who use tobacco and cannabis products miss more school and have lower grades than classmates who use them individually or not at all. That's...

U.S. Food and Drug Administration (FDA) Has Accepted the New Drug Application (NDA) for Ensartinib

(BUSINESS WIRE) March 13, 2024 --Xcovery Holdings, Inc., an oncology focused pharmaceutical company, today announced that the U.S. Food and Drug Administration...

FDA Revises Letter of Authorization for the Emergency Use Authorization for Paxlovid

EUA-labeled Paxlovid is no longer authorized for emergency use, regardless of the labeled or extended expiration date. For both NDA-approved and EUA-authorized...

Vitamin D Plus Calcium: Good News, Bad News for Older Women

Women who've gone through menopause and hope that supplemental vitamin D plus calcium might shield them from disease may be disappointed by new data. A...

Par Pharmaceutical Issues Voluntary Nationwide Recall of One Lot of Treprostinil Injection Due to Potential for Silicone Particulates

March 12, 2024 – DUBLIN, Ireland – Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par),...

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Recently added consumer and prescribing information: Tevimbra, Rezdiffra, Tyenne, Wyost, Letybo, Simlandi, Amtagvi, Casgevy, Ogsiveo, DefenCath

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Latest FDA New Drug Approvals

  • Lenmeldy Lenmeldy (atidarsagene autotemcel) is an autologous hematopoietic stem cell (HSC) gene therapy for the treatment of children with...
  • Rezdiffra Rezdiffra (resmetirom) is a thyroid hormone receptor-beta (THR-beta) agonist indicated in conjunction with diet and exercise for the...
  • Tevimbra Tevimbra (tislelizumab-jsgr) is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of adult patients with...

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