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.
Federal Register notice: FDA issues a final rule to revoke the regulations for human tissue intended for transplantation and human dura mater recovere...
Federal Register notice: FDA issues a final rule to amend the medical device regulations on procedures for announcing approvals and denials of PMAs an...
FDA clears an Abbott 510(k) for the EnSite EP System with EnSite Omnipolar Technology, a new cardiac mapping platform designed to help physicians bett...
FDA releases an FDA-483 with seven observations from an inspection at Longview, TX-based Med Shop Total Care.