FDA accepts for review six Merck supplemental BLAs to update the dosing frequency for Keytruda (pembrolizumab).
FDA releases the FDA-483 with four observations from an inspection at Indias Indoco Remedies.
FDA warns Akorn about CGMP violations at its Somerset, NJ, drug manufacturing facility, as well as similar violations at other facilities.
FDA releases its latest batch of Warning Letters that includes Akorn, AllerQuest, Clinicon, Izeen Pharma and U.S. Pharmaceuticals.
FDA releases the FDA-483 with two observations from an inspection at the Dr. Reddys Andhra Pradesh drug manufacturing facility.
FDA warns Clinicon about Quality System violations in its manufacturing of SureProbe laser accessory probes.
CDER issues a MAPP on policies and procedures for FDA Amendments Act safety labeling changes.
The Tufts Center for the Study of Drug Development reports that drug development targeting rare diseases is one of the fastest growing and one of the ...