FDA clears a Medtronic 510(k) for its Nexpowder endoscopic hemostasis system.
FDA approves Amylyxs amyotrophic lateral sclerosis (ALS; also known as Lou Gehrig's disease) drug AMX0035 (sodium phenylbutyrate and taurursodiol).
FDA publishes a guidance on preparing 510(k) submissions for display devices intended for diagnostic radiology.
FDA publishes a revised guidance on medical device data systems to conform with the 21st Century Cures Act.
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug applications and abbreviate...
Federal Register notice: FDA announces a 10/26 public meeting entitled Animal Generic Drug User Fee Act.
FDA joins with the NIH and other organizations in a new Accelerating Medicines Partnership program on heart failure.
Sarepta Therapeutics files a BLA seeking accelerated approval of SRP-9001 (delandistrogene moxeparvovec) to treat ambulant patients with Duchenne musc...
