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 ...

The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and ...

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

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 ...

The FDA accepted Aldeyra's resubmitted NDA for reproxalap after previous rejections due to efficacy concerns, despite no ...

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 ...

To assess new drugs for safety and effectiveness, the FDA relies on premarket drug testing and clinical trials. Most of the trials involve fewer than 1,000 patients studied over a period of six months ...

Many FDA Scientists Had Drug Concerns, ... official review said they had been pressured to recommend approval of a new drug despite reservations about its safety, effectiveness or quality. ...

Tarrytown, N.Y.-based Regeneron Pharmaceuticals said the FDA declined to approve its blood cancer therapy for two forms of lymphoma over concerns about the ongoing confirmatory trials. The company ...

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