FDA opens a broad investigation into reports of deaths in adults that may be linked to Covid-19 vaccines after probing pediatric deaths allegedly tied...
Two pharmacist-attorneys (BakerHostetler) urge Congress to strengthen federal restrictions on how senior FDA officials move into private-sector roles,...
Draeger recalls (Class 1) its ErgoStar CM 60 (catheter mount 60), an airway connector/catheter mount, after receiving multiple complaints reporting de...
CDER issues a Manual of Policies and Procedures for when a reference-listed drug switches from prescription to nonprescription marketing status and AN...
A biosimilars scholar files a citizen petition urging FDA to dramatically streamline and modernize its biosimilar approval requirements.
FDA approves Gamida Cells Omisirge, the first cellular therapy authorized to treat patients with severe aplastic anemia.
FDA postpones a promised safety review of the abortion drug mifepristone and is now not likely to be released until after the 2026 midterm elections.
BioNTech and OncoC4 say their investigational immunotherapy gotistobart significantly extended survival for certain patients with advanced squamous no...
