News Warning letter adds to Applied Tx run of bad news Applied Therapeutics gets a warning letter from the FDA over a trial of rare disease drug govorestat, which was rejected by the agency last week.
News FDA warns of genital gangrene risk with diabetes drug class The US regulator released an official risk warning of a rare genital infection identified in 12 patients, including one fatality, after using SGLT2 class drugs for type 2 diabetes.
News Just how radical is the FDA's complete response letter move? The FDA says publishing complete response letters for medicines is an act of "radical transparency," but it is not as revolutionary as it seems.
Market Access The value of a partner, globally and locally A new podcast looks at recent trends related to drug approvals, as well as challenges and opportunities both small and large pharma companies face