FDA releases the FDA-483 with four observations from an inspection at Fenton, MO-based SSM St. Clare Health Center.
FDA updates its 12/2020 safety communication on Endologixs AFX endovascular graft systems used in treating abdominal aortic aneurysms and the risks as...
FDA approves Mentors MemoryGel Boost Breast Implant for breast augmentation in women at least 22 years old, and for women of all ages undergoing breas...
FDA revises fact sheets for the Janssen Covid-19 vaccine to discuss the risk of immune thrombocytopenia during the 42 days after vaccination.
FDA extends the expiration date on about one million unused Covid test kits in Florida.
FDA warns patients and providers about the potential for dental problems associated with dissolving buprenorphine products in the mouth to treat opioi...
FDA accepts for priority review a Mitsubishi Tanabe Pharma America NDA for edaravone (MT-1186) for treating amyotrophic lateral sclerosis.
Washington University in St. Louis law professor Rachel Sachs says a CMS restricted coverage determination for Biogens Aduhelm adds to questions about...