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

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 ...

The FDA staffers on Wednesday cited efficacy issues related to a combination regimen involving brexpiprazole, an antipsychotic medication developed by Otsuka Pharma (OTCPK:OTSKY) and H. Lundbeck ...

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 Food and Drug Administration (FDA) announced a proposal to remove oral phenylephrine as an active ingredient in over-the-counter (OTC) drug products due to efficacy concerns.

FDA looking into dental device after joint CBS News-KHN investigation 05:27. In the wake of a CBS News-KHN investigation, the FDA on Thursday said it is "evaluating safety concerns" over the use ...

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