FDA approves an expanded use for Johnson & Johnsons Caplyta (lumateperone) as an adjunctive therapy with oral antidepressants in adults with major dep...
Rep. Abe Hamadeh calls on FDA to suspend any enforcement actions against desiccated thyroid medications due to the possibility that they stemmed from ...
Addressing a Milken Institute annual summit, FDA commissioner Marty Makary reassures stakeholders that despite recent departures among its senior rank...
Centessa Pharmaceuticals reports encouraging clinical data for its oral OX2R agonist ORX750 in patients with narcolepsy Types 1 and 2 and idiopathic h...
FDA warns Liebel-Flarsheim in Raleigh, NC, about CGMP violations in its production of finished drugs.
FDA releases the form FDA-483 with four observations from an inspection at the Alembic Pharmaceuticals active pharmaceutical ingredient manufacturing ...
A STAT report highlighted in Medpage says CBER employees are concerned about the environment established by their new director, Vinay Prasad.
FDA issues Biohaven a complete response letter, rejecting the companys NDA for Vyglxia (troriluzole) as a treatment for spinocerebellar ataxia.
