Former Sen. Ben Sasse, 54, called daraxonrasib "a miracle drug" that was allowing him to live longer and with less pain.
FDA drug alerts in infectious diseases, including new drug approvals, safety warnings, recalls, and changes in indications.
The FDA rejected the promising skin cancer drug RP1 twice, leaving many puzzled and worried about what this means for other ...
By Padmanabhan Ananthan May 1 (Reuters) - The U.S. Food and Drug Administration on Friday approved Pfizer and Arvinas' breast ...
Oral NMDA receptor antagonist gets an expanded indication ...
The FDA has renewed calls for Amgen’s Tavneos to be pulled from the market, saying it has discovered new evidence that study ...
The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics Lic ...
US regulators have withdrawn their approval of a GSK Plc drug that the Trump administration had promoted as a treatment for autism, adding another twist to the unusual story of a decades-old drug.
The US Food and Drug Administration (FDA) based its approvals for most novel drugs on single studies during 2022, according to findings from a cross-sectional analysis published as a research letter ...