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

The Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 10-1 against the approval of brexpiprazole in combination with sertraline for the treatment of adults ...

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 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 ...

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 ...

There are only two FDA-approved treatments for PTSD. MDMA would be the first to come on the market in decades. Though classified as a Schedule I drug, the FDA granted MDMA "breakthrough therapy ...

“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 decision was a huge disappointment to advocates of a treatment that the FDA recognized as a "breakthrough therapy" in 2017—especially since the two Phase 3 trials, which were published by ...

The letters were sent as the FDA prepares to issue by Aug. 11 a decision on MDMA, commonly known as ecstasy, to treat PTSD. The treatment is controversial and faces significant hurdles to approval ...