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.
Getinge recalls its CardioHelp Emergency Drive due to a possible blocking or impairment of its emergency crank.
Federal Register notice: FDA withdraws approval of Bayers Cipro (ciprofloxacin HCl) oral tablets under NDA #019537 and five related ANDAs that referen...
Federal Register notice: FDA sends to OMB an information collection revision entitled Time and Extent Applications (TEA) for Nonprescription Drug Prod...
