Former FDA chief counsel Dan Troy joins Berkeley Research Group in the firms Washington, DC office as a managing director in its Health Analytics pra...
FDA approves an AstraZeneca BLA for Beyfortus (nirsevimab-alip) for preventing Respiratory Syncytial Virus lower respiratory tract disease in neonates...
Federal Register notice: FDA announces the issuance of a priority review voucher to Sarepta Therapeutics for its recently approved rare pediatric dise...
FDA issues a warning against using ultrasound medical devices manufactured and distributed by RoyalVibe Health, and related companies CellQuicken and ...
Eli Lilly reports study results showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheime...
BridgeBio Pharma plans to file an NDA after reporting positive results from ATTRibute-CM, a Phase 3 study of acoramidis in transthyretin amyloid cardi...
Federal Register notice: FDA and the Clinical Trials Transformation Initiative seek patient advocates interested in participating on the Patient Engag...
FDA issues Fresenius Kabis Canton, MA outsourcing facility a Form FDA-483 over GMP deviations observed during a March inspection.
