Medtronic recalls all unused Valiant Navion thoracic stent grafts and informed physicians to immediately stop using the device until further notice du...
FDA grants a de novo marketing authorization to Q30 Sports Science for its Q-Collar, a device intended to be worn around the neck of athletes aged 13 ...
FDA approves an Amneal Pharmaceuticals ANDA for 150 mcg/day norelgestromin and 35 mcg/day ethinyl estradiol transdermal system, a generic copy of now-...
FDA approves B. Braun Medicals acetaminophen injection in IV bags in 1,000 mg in 100 mL and 500 mg in 50 mL doses.
FDA asks Merck for additional data beyond a recently completed Phase 3 study of investigational Covid-19 drug MK-7110, an immune modulator.
An FDA advisory committee votes 22-0 to support an emergency use authorization for Janssen Biotechs single intramuscular Covid-19 vaccine injection.
A Consumer Reports investigative report says FDA showed no urgency in 2018 to take action against a dietary supplement with opioid-like effects.
The Biden administration adds former FDA chief of staff Lauren Silvis to its Covid-19 response team.