FDA releases an FDA-483 with three observations from an inspection at Indias Alembic Pharmaceuticals.
FDA warns Tris Pharma about CGMP violations in the manufacture of finished pharmaceuticals under contract to Pfizer.
Federal Register notice: FDA has announced three product approvals that redeemed a priority review voucher.
Patients for Access to Advanced Hemophilia Therapy asks FDA for a public hearing on whether patent suits have an adverse effect on the delivery of med...
FDA releases its latest batch of Warning Letters that includes South Texas Botanicals and Tris Pharma.
FDA accepts for priority review a Verastem NDA for its lead product candidate duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-ki...
FDA clears a Varian 510(k) for a new version of its Velocity cancer imaging software which includes Rapidsphere, a module for Y90 Selective Internal R...
FDA approves a Pacira Pharmaceuticals NDA for Exparel (bupivacaine liposome injectable suspension) for expanded use as an interscalene brachial plexus...