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...
BioNTech and OncoC4 say their investigational immunotherapy gotistobart significantly extended survival for certain patients with advanced squamous no...
FDA delays its review decision on an Agios Pharmaceuticals supplemental NDA for mitapivat, its oral therapy for adults with both transfusion-dependent...
Dyne Therapeutics reports positive topline results from its Phase 1/2 DELIVER trial of z-rostudirsen (DYNE-251), saying the investigational exon-skipp...
Top House Democrats demand FDA provide documents and explanations after revelations that a senior FDA official circulated new vaccine development guid...
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.
