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 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 ...

A U.S. Food and Drug Administration (FDA) advisory panel has voted overwhelmingly against the approval of Otsuka ...

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

FDA reviewers flag "discordant results" in a briefing document published ahead of Friday's advisory committee meeting for the ...

In a 10-1 vote, the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee said Otsuka Pharmaceutical Co. Ltd.’s studies of its combination post-traumatic stress disorder (PTSD) treatment did not ...

Drugmaker Lykos Therapeutics had asked the FDA to approve its MDMA capsules as part of a therapy regimen they argued could be a breakthrough for treating challenging cases of PTSD.. Lykos said the ...

WASHINGTON (AP) — A first-of-a-kind proposal to begin using the mind-altering drug MDMA as a treatment for PTSD was roundly criticized Tuesday — a potentially major setback to psychedelic ...