FDA warns Orlando, FL-based Platinum Biologics that it is illegally marketing unapproved new drugs.
FDA releases the form FDA-483 with four observations from an inspection at the Dayton, NJ-based Hikma Injectables USA outsourcing facility.
More than 260 reproductive health researchers urge FDA to continue to support mifepristone based on its 25-year record of safety and effectiveness in ...
FDA says it has accepted an Echosens Letter of Intent to develop Liver Stiffness Measurement by Vibration-Controlled Transient Elastography as a surro...
FDA accepts for review a Grace Therapeutics NDA for GTx-104 (nimodipine for injection) for treating patients with aneurysmal subarachnoid hemorrhage.
Amylyx Pharmaceuticals discontinues development of its investigational therapy AMX0035 (sodium phenylbutyrate and taurursodiol) in progressive supranu...
FDA issues an alert after becoming aware that Abiomed sent a letter to customers recommending that certain automated Impella controllers be removed fr...
BioXcel Therapeutics plans an early 2026 supplemental NDA submission to expand the label of its agitation treatment Igalmi (BXCL501) for unsupervised ...
