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 ...

Treatments for bronchiectasis, chronic immune thrombocytopenia, fibromyalgia, Friedreich ataxia, and recurrent respiratory papillomatosis are under review.

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

The controversial drugs are not yet approved, but advocates hope a NC law would allow the state to be ready, should the FDA approve them.

The prospect of Lundbeck and Otsuka’s Rexulti becoming part of a new treatment for post-traumatic stress disorder (PTSD) ...

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

Otsuka Pharmaceutical Co.’s medicine for post-traumatic stress disorder with partner H. Lundbeck A/S failed to win the backing of US regulatory advisers, a major setback in the drugmakers’ bid to ...

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

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 ...

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

Health Secretary Robert F. Kennedy Jr. and other Trump officials are signaling their interest in approving psychedelic drugs ...

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