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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]
CDER issues a Manual of Policies and Procedures for when a reference-listed drug switches from prescription to nonprescription mar...[ 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...[ Price : $8.95]
BioNTech and OncoC4 say their investigational immunotherapy gotistobart significantly extended survival for certain patients with ...[ Price : $8.95]
FDA delays its review decision on an Agios Pharmaceuticals supplemental NDA for mitapivat, its oral therapy for adults with both t...[ Price : $8.95]
Dyne Therapeutics reports positive topline results from its Phase 1/2 DELIVER trial of z-rostudirsen (DYNE-251), saying the invest...