FDA gives Catalent a four-page Form FDA-483 after inspecting the firms Bloomington, IN manufacturing facility 5/4-12.
Quidel Cardiovascular recalls the Quidel Triage Cardiac Panel after reports of inaccurate tests showing lower-than-expected troponin levels in samples...
FDA updates its final guidance entitled Qualification of Medical Device Development Tools (MDDTs).
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...
