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...
Novartis and Molecular Partners say they plan to seek an FDA emergency use authorization after reporting results from the EMPATHY clinical trial that...
Harvard Medical School researchers say the use of skinny labeling in generic forms of Novartis Gleevec allowed the generics to enter the market before...
FDA accepts an IND for a PharmaTher Phase 2 trial of ketamine to treat ALS.