Stanford's George Tidmarsh has authored 143 scientific papers and patents, as well as played a central role in developing ...

The U.S. Food and Drug Administration named ex-biotech exec George Tidmarsh as its chief drug regulator. FDA Commissioner ...

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 ...

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 have attracted attention from regulators ...

The Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 10-1 against the approval of brexpiprazole in combination with sertraline for the treatment of adults ...

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

An FDA advisory panel concludes that the efficacy of brexpiprazole, when started concurrently with sertraline, has not been ...

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

Scientists at UCSF and Gladstone Institutes have identified cancer drugs that promise to reverse the changes that occur in ...

Replimune shares collapsed on Tuesday after the U.S. Food and Drug Administration rejected the clinical-stage biotechnology company's proposed advanced melanoma treatment. Shares of the Woburn, Mass., ...