Psychiatrist David Behar petitions FDA to remove the clozapine REMS program and allow providers to use their clinical judgment in monitoring patients ...
FDA warns Pfizer Healthcare India about a CGMP violation in its production of finished drugs.
CME America recalls the BodyGuard Infusion Pump Systems because the pumps may under or over infuse medications.
PhRMA submits additional comments on the FDA 2/24 Rare Disease Day public meeting.
FDA ends its probe of Novartis Zolgensma data manipulation and waives any regulatory action against the company.
Nevadas federal court rules against Amarin in a patent dispute with two generic drug companies over its Vascepa heart drug.
FDA describes its Coronavirus Treatment Acceleration Program to speed the development and deployment of Covid-19 therapies.
FDA accepts a Bristol Myers Squibb and Bluebird Bio BLA for idecabtagene vicleucel, a B-cell maturation antigen-directed chimeric antigen receptor T c...