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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...[ Price : $8.95]
Top House Democrats demand FDA provide documents and explanations after revelations that a senior FDA official circulated new vacc...[ Price : $8.95]
Praxis Precision Medicines says its experimental epilepsy drug relutrigine produced positive results in a key study, prompting an ...