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.
FDA says it will update regulations to clarify the types of evidence it considers when determining the intended use of a medical product.
Federal Register notice: FDA makes available a draft guidance entitled Draft Guidance for Cannabidiol.
Federal Register notice: FDA announces an 11/19 public meeting Webcast entitled CBD and Other Cannabinoids: Sex and Gender Differences in Use and Resp...
FDA alerts health care professionals and patients to a recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma So...