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 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 ...

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 ...

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

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

The FDA is scheduled to announce its decision on PTC Therapeutics' investigational drug, Sepiapterin, proposed for the treatment of pediatric and adult patients with phenylketonuria, on July 29, 2025.

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 ...

Republicans now support counterculture drug research, while Democrats have become cautious about unproven medical treatments.

A new scientific integrity project aims to find “bad medical evidence before it kills people.” ...