FDA alerts health care professionals and patients to a recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma So...
FDA releases its latest batch of Warning Letters that include Coupler Enterprises and HNC Products.
The Washington Post reports that FDA will issue a new guidance for Covid-19 vaccines that will tighten emergency authorization standards and most like...
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...