FDA commissioner Stephen Hahn and CDC director Robert Redfield dismiss notions that a deep state operates within their agencies intent on damaging pre...
FDA warns HNC products about significant violations of CGMP regulations in its production of OTC drugs.
The U.S. House passes two bills having wide implications for FDA in supporting Continuous Pharmaceutical Manufacturing and combating counterfeit medic...
Federal Register notice: FDA corrects a 7/29 final rule requiring electronic submission of certain postmarketing safety reports for approved new anima...
Hikma says it expects final FDA approval of its ANDA for a generic form of GSKs Advair Diskus early next year.
FDA says it will give priority review to a BLA submitted by Bristol-Myers Squibb and bluebird bio for their ide-cel, the first CAR T cell therapy acce...
FDA says it is launching a Digital Health Center of Excellence within CDRH.
FDA warns Coupler Enterprises about CGMP violations in its manufacturing of finished drugs.