Alzheimer’s disease remains one of medicine’s toughest challenges, affecting millions and costing trillions of dollars ...

The FDA’s decision to reject Replimune’s (NASDAQ:REPL) lead asset RP1 for a type of skin cancer known as melanoma appears to ...

Replimune, which was seeking approval of RP1 in combination with Bristol Myers Squibb's Opdivo for the treatment of advanced melanoma, on Tuesday said the FDA issued a so-called complete response ...

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...

Treatments for bronchiectasis, chronic immune thrombocytopenia, fibromyalgia, Friedreich ataxia, and recurrent respiratory papillomatosis are under review.

The U.S. Food and Drug Administration has approved GSK's prefilled syringe presentation of Shingrix (zoster vaccine ...

The Food and Drug Administration has granted permission for Juul to continue selling its e-cigarettes, offering some reprieve ...

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

FDA regulators said Thursday that Juul’s studies show its e-cigarettes are less harmful for adult smokers, who can benefit ...

The U.S. Food and Drug Administration said on Monday it has appointed George Tidmarsh, a seasoned biotech executive and ...

The FDA is now fast-tracking new drug approvals — why that’s so worrying By . Marc Lallanilla. Published Aug. 24, 2023. Updated Aug. 24, 2023, 6:38 p.m. ET. Explore More ...

Pro-life medical groups are urging Health and Human Services Secretary Robert Kennedy Jr. to reexamine the FDA’s broad ...