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FDA warns Saint Paul, MN-based Envoy Medical about Quality System violations in its manufacturing of the Esteem II implantable hea...[ Price : $8.95]
FDA opens a broad investigation into reports of deaths in adults that may be linked to Covid-19 vaccines after probing pediatric d...[ Price : $8.95]
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 ...