The US FDA has published more than 200 complete response letters sent as replies to drug and biological product applications.

Dr. Makary joined NewsNation to discuss his first 100 days FDA Commissioner: 'People forget that the ‘F’ in FDA stands for food' FDA focused on fighting childhood obesity and diabetes As part of the ...

The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with ...

The FDA has accepted the New Drug Application for ET-600, an oral solution formulation of desmopressin, for the treatment of central diabetes insipidus.

The FDA is expected to decide on treatments for bronchiectasis, chronic immune thrombocytopenia, fibromyalgia, Friedreich ataxia, and recurrent respiratory papillomatosis.

The FDA said yesterday that it is investigating the deaths from liver failure of two non-ambulatory boys with Duchenne muscular dystrophy who were treated with Sarepta Therapeutics’ gene therapy ...

A drug currently used to treat certain HIV infections has also, on Wednesday, received approval from the US Food and Drug Administration to be used to prevent HIV.

The Food & Drug Administration (FDA) is warning consumers and businesses about Emek-brand pistachio cream, imported from Turkey, after four reported salmonella illnesses in Minnesota and New ...

FDA assigns PDUFA target action date of January 31, 2026 WARREN, N.J., June 16, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a ...

NATCO Pharma said that the U.S. Food and Drug Administration (FDA) had conducted an inspection at the API manufacturing plant located in Mekaguda, Hyderabad, India, which was conducted from 09 to 13 ...

CNBC-TV18 had first reported the US FDA's surprise visit on June 3. The regulator has now issued a Form 483 with eight observations after a GMP inspection at Sun Pharma’s Halol unit.

Sun Pharmaceutical Industries has informed that the US FDA conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharmaceutical Industries Limited's Halol facility (Gujarat, India) from 02 ...