FDA grants Eli Lilly accelerated approval for Jaypirca (pirtobrutinib) for treating certain relapsed or refractory mantle cell lymphoma patients.
House leaders tap Representative Brett Guthrie (R-KY) to serve as chair of the House Energy and Commerce Committees Health Subcommittee, which oversee...
Two Hyman, Phelps & McNamara attorneys describe requirements in the new Food and Drug Omnibus Reform Act to improve clinical trial diversity.
FDA principal deputy commissioner Janet Woodcock says the agency will work with Congress to develop a new cross-agency regulatory framework for cannab...
Federal Register notice: FDA announces a 3/9 Oncologic Drugs Advisory Committee meeting to discuss a supplemental BLA for Genentechs Polivy (polatuzum...
Federal Register notice: FDA issues a three-year debarment order against Poornanand Palaparty for receiving and distributing prescription oncology dru...
FDA commissioner Robert Califf and CBER director Peter Marks explain why biological therapies should be tested in randomized controlled trials.
Two professors call for updates to the FDA system for regulating drug promotion to account for new businesses that are promoting drugs through social ...
