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

The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's ...

An FDA advisory panel will meet July 18 to consider a supplemental new drug application for the antipsychotic brexpiprazole, ...

The FDA has approved Juul Labs' tobacco and menthol e-cigarettes, marking a significant decision amidst regulatory challenges ...

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

The FDA is raising efficacy questions over Lundbeck and Otsuka’s proposed combination of their Rexulti with Viatris’ Zoloft ...

The FDA decision, scheduled for August 11, could mark a turning point in the treatment of PTSD. Concerns and criticisms surround the integrity of clinical trials, highlighting the lack of ...

June 05, 2024 FDA advisory panel votes against MDMA for treatment of PTSD Concerns about the safety of the psychedelic drug and the way studies were conducted led to the decision.

Veterans, members of Congress, and many others advocated for the groundbreaking PTSD treatment, but the FDA declined it saying more research is needed. By Joshua Skovlund Updated Aug 12, 2024 2:37 ...

The U.S. Food and Drug Administration announced Friday its rejection of MDMA as a treatment for PTSD. ... The FDA’s decision comes nearly eight weeks after an FDA advisory committee voted 10-1 ...

“Our country has a severe veteran suicide and PTSD crisis where 6,000 veterans die by suicide each year, with over 150,000 suicides since 9/11,” the Senate letter to FDA Commissioner Dr ...

The FDA’s decision shines a light on some of the unique ... voted overwhelmingly against the idea that the relevant clinical trials had proved the efficacy of MDMA for the treatment of PTSD.