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Two pharmacist-attorneys (BakerHostetler) urge Congress to strengthen federal restrictions on how senior FDA officials move into p...[ Price : $8.95]
CBER officials pen a new JAMA article signaling a major policy shift for cancer CAR T-cell therapies, moving away from reliance on...[ Price : $8.95]
Four Hogan Lovells attorneys describe a potential significant shift in Justice Department enforcement boundaries, especially invol...[ Price : $8.95]
FDA warns Massena, NY-based Seaway Pharma about long-standing CGMP violations in its production of finished drugs as a contract ma...[ Price : $8.95]
FDA approves Augmentin XR (amoxicillinclavulanate potassium) through the new Commissioners National Priority Voucher pilot program...[ Price : $8.95]
A biosimilars scholar files a citizen petition urging FDA to dramatically streamline and modernize its biosimilar approval require...[ Price : $8.95]
FDA approves Gamida Cells Omisirge, the first cellular therapy authorized to treat patients with severe aplastic anemia.[ Price : $8.95]
FDA postpones a promised safety review of the abortion drug mifepristone and is now not likely to be released until after the 2026...