FDA accepts an Ascendis Pharma NDA resubmission for TransCon PTH (palopegteriparatide) for treating adults with hypoparathyroidism.
Ciplas InvaGen Pharmaceuticals unit recalls one lot of vigabatrin for oral solution, USP 500mg, due to seal integrity issues.
People for the Ethical Treatment of Animals urges FDA to move away from animal experiments in its labs and use more non-animal, human-relevant researc...
FDA accepts for review a Pfizer BLA for its anti-tissue factor pathway inhibitor candidate marstacimab for treating hemophilia A or hemophilia B.
Trump-associated America First Legal files a lawsuit against FDA and HHS for illegally concealing government records related to the suppression of hyd...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Peloton Therapeutics Welireg (belzutifan).
Cardinal Health recalls its Covidien and Cardinal Health brand urology and operating room-specific kits and trays that contain 0.9% sodium chloride ir...
FDA issues a guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.
