Addressing a Milken Institute annual summit, FDA commissioner Marty Makary reassures stakeholders that despite recent departures among its senior rank...
FDA issues a Warning Letter to Apotex, citing significant GMP violations at the companys Richmond Hill, Ontario, facility, including failures in steri...
FDA warns Waunakee, WI-based Scientific Protein Laboratories about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
Politico reports that President Trump and HHS are standing by FDA commissioner Marty Makary as the agency weathers the sudden departure of CDER direct...
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.
