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.
GC Pharma submits a BLA for GC5107 (immune globulin intravenous (human),10% liquid) for treating patients with primary humoral immunodeficiency diseas...
Federal Register notice: FDA amends its animal drug regulations to reflect the withdrawal of approval of seven new animal drug applications due to lac...
FDA approves an AbbVie supplemental BLA for Humira (adalimumab) for treating moderately to severely active ulcerative colitis in pediatric patients fi...