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...
Praxis Precision Medicines says its experimental epilepsy drug relutrigine produced positive results in a key study, prompting an independent committe...
FDA investigators issue a 24-page Form FDA-483 citing numerous manufacturing violations after a 12-day inspection in May of Apotexs sterile drug facil...
CDCs Advisory Committee on Immunization Practices votes to discontinue the longstanding policy that all newborns receive the Hepatitis B vaccine withi...
An FDA advisory committee votes unanimously against recommending approval of Johnson & Johnsons V-Wave heart shunt for patients with advanced heart fa...
