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

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 ...

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

Moderna has scrapped plans to build an mRNA plant in Japan. Otsuka and Lundbeck's proposal for Rexulti as part of a PTSD ...

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 ...

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 ...

An FDA advisory panel will meet July 18 to consider a supplemental new drug application for the antipsychotic brexpiprazole, ...

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 ...

Then in August, the Food and Drug Administration rejected drugmaker Lykos Therapeutics’ application to offer ecstasy, alongside therapy, as a treatment for PTSD. FDA advisers worried ... advocates ...