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

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (CT03767348) trial in advanced melanoma was not ...

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

Replimune faces FDA hurdles for RP1, an innovative melanoma treatment, as it seeks a path forward after receiving a complete ...

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

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

Staff reviewers at the U.S. Food and Drug Administration said on Wednesday a confirmatory trial did not show the effectiveness of Intercept's liver disease drug, which received the health ...

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 ...

Class II recalls from the FDA indicate a potential risk to consumer safety where use or exposure to the product may cause ...

FDA expresses concerns about lupus drug's effectiveness. By Steven Overly. November 15, 2010 at 12:00 a.m. EST.

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