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

The panel voted 10-1 to say the available data does not establish the efficacy of the drug, brexpiprazole, in combination ...

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

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

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

The controversial drugs are not yet approved by federal regulators, butadvocates hope a NC law would allow the state to be ...

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

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 ...

RFK Jr. and other Trump officials are backing psychedelics after the FDA rejected MDMA therapy. Now, Texas and federal ...

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

His suggested timeline for green-lighting psychedelic therapy surprised even the most bullish supporters of the drugs.