NRx together with Osmind, Inc. conducted an in-person meeting attended by leadership of the FDA Division of Psychiatry ...

This productive discussion with FDA reviewers gives Ernest leadership renewed confidence our development plan is on the ...

Outlook Therapeutics believes this determination is inconsistent with the totality of evidence submitted in the BLA, including data from an adequate and well-controlled study and confirmatory evidence ...

Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) on Tuesday received the final meeting minutes from its End of Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration (FDA) held in July. The ...

Solid Biosciences Inc. is a Strong Buy driven by positive FDA alignment on phase 3 IMPACT DUCHENNE trial for SGT-003. Read ...

The FDA will hold a public meeting July 9 to allow adult and pediatric patients to give the agency their perspectives on the effects of chronic pain, treatment approaches for chronic pain and barriers ...

Corcept’s relacorilant was rejected for hypercortisolism late last year—a decision which CEO Joseph Belanoff expressed surprise with at the time.