FDA grants Epizyme accelerated approval for Tazverik (tazemetostat), an EZH2 inhibitor for certain adult patients with relapsed or refractory follicul...
Federal Register notice: FDA makes available a final guidance on Patient-Focused Drug Development: Collecting Comprehensive and Representative Input....
FDA issues an immediately-in-effect guidance on statistical considerations for proposed changes to clinical trials that may affect the analysis or int...
The Council for Responsible Nutrition asks FDA to lay out a regulatory pathway for approval of hemp-derived cannabidiol in dietary supplements.
Federal Register notice: FDA seeks comments on an information collection extension for Obtaining Information to Understand Challenges and Opportunitie...
The watchdog group Accountable.US asks attorney general William Barr to be transparent about any political interference in a price-fixing investigatio...
Federal Register notice: FDA requests nominations for members to serve on its Pharmacy Compounding Advisory Committee.
FDA updates Covid-19 molecular test templates to help developers get tests authorized for broad screening of asymptomatic individuals.