FDA publishes a draft guidance entitled Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Drug Development Programs for Treatment.
Federal Register notice: FDA withdraws approval of eight ANDAs from multiple applicants after they informed the agency that the products were no longe...
FDA approves Pfizers Abrysvo vaccine to prevent respiratory syncytial virus in older adults.
FDA approves AstraZeneca and Mercks Lynparza (olaparib) in combination with Janssens Zytiga (abiraterone) and prednisone or prednisolone for treating ...
FDA publishes a draft guidance on the clinical development of drugs to prevent migraine.
AstraZeneca says it is ending its brazikumab development program that was being studied for Crohns disease and ulcerative colitis.
FDA issues a warning against using unapproved products that claim to treat molluscum.
FDA commissioner Robert Califf says he sees value in artificial intelligence and agrees that its important to also look at the risk of harm that can b...