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...
FDA approves Regeneron Pharmaceuticals Dupixent (dupilumab) for treating adult patients with prurigo nodularis. a chronic, inflammatory skin disease.
Four stakeholders suggest ways FDA could improve a draft guidance on fit-for-use clinical outcome assessments.
FDA approves Bimeda Animal Healths SpectoGard (spectinomycin sulfate), the first generic copy of Pharmacia Animal Healths Adspec.
