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

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

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

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

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

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

The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.

Replimune said the agency had issued a complete response letter regarding the company’s biologics license application for RP1 ...

The Trump administration is inching closer to banning fluoride tablets and drops often prescribed to kids who don’t have ...

On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...

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 ...

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