The U.S. Food and Drug Administration's reviewers on Wednesday raised efficacy concerns over the use of Otsuka Pharma's drug ...

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

Biotech veteran and Stanford physician-scientist brings 30 years of translational research and regulatory experience to ...

Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ...

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

The US Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ...

FDA advisers on Thursday voted against GSK's blood cancer drug Blenrep, finding that its risks outweighed its benefits at the ...

Otsuka Pharma (OTCPK:OTSKY) and H. Lundbeck (OTCPK:HLBBF) draws efficacy concerns for their PTSD therapy from the FDA ahead ...

putting the onus on the drug companies to share that information, which they often do selectively. According to a 2015 FDA ...

The decision follows an earlier vote from FDA advisors, who rejected the MDMA-assisted therapy in June.The panel questioned the treatment’s long-term efficacy and safety, the quality of Lykos ...

Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s ...

The U.S. Food and Drug Administration's reviewers have raised efficacy concerns over Otsuka Pharma's combination drug for ...