FDA sends Athenex a complete response letter on an NDA for oral paclitaxel plus encequidar for treating metastatic breast cancer due to, among other i...
Empirical Spine says it will submit a rolling PMA for its LimiFlex Paraspinous Tension Band for treating patients suffering from degenerative spondylo...
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.