FDA approves a Madrigal Pharmaceuticals NDA for Rezdiffra (resmetirom) for treating adults with noncirrhotic non-alcoholic steatohepatitis.
FDA publishes a draft ICH guidance on post-marketing individual case study reporting.
FDA medical reviewers ask the Oncology Drug Advisory Committee to weigh the benefits of the benefits and serious risks of Gerons imetelstat to treat s...
FDA asks the Oncologic Drugs Advisory Committee to evaluate the higher risk of early deaths in trials supporting sBLAs for Celgenes Abecma and Janssen...
Mintz attorney Benjamin Zegarelli says FDA needs to develop creative ways to regulate software as a medical device while it waits for Congress to give...
FDA associate commissioner for global policy and strategy Mark Abdoo says the agency is requesting funds to begin expanding its foreign operations.
A petition submitted by a Charles Ludlam calls on FDA to require additional clinical trials to examine the loss of lean muscle mass associated with us...
FDA grants MindMed a breakthrough designation for its MM120 (lysergide d-tartrate) program for treating generalized anxiety disorder.
