FDA announces a 9/17 virtual public workshop entitled Spinal Device Clinical Review.
Federal Register notice: FDA determines that Boehringer Ingelheim Pharmaceuticals Atrovent (ipratropium bromide) metered spray 0.021 mcg and 0.042 mcg...
FDA grants accelerated approval for Biogens Aduhelm (aducanumab), the first drug since 2003 approved for treating Alzheimers.
FDA approves a Medtronic PMA for the SenSight Directional Lead System used for deep brain stimulation therapy.
FDA approves an Alexion Pharmaceuticals BLA for Ultomiris (ravulizumab-cwvz) injection and its use in treating patients aged one month and older with ...
FDA lifts clinical holds against Bluebird Bios Phase 1/2 (HGB-206) and Phase 3 (HGB-210) studies of LentiGlobin gene therapy for sickle cell disease. ...
FDA approves a ProMetic Biotherapeutics BLA for Ryplazim (plasminogen, human-tmvh) for treating patients with plasminogen deficiency Type 1.