Philips Respironics announces it has set aside $615 million under an agreement to resolve all economic loss claims in a class action lawsuit related t...
FDA releases a draft guidance entitled Endogenous Cushings Syndrome: Developing Drugs for Treatment.
Janssen Pharmaceutical discontines, due to futility, its Phase 3 MACiTEPH study evaluating macitentan 75 mg in patients with chronic thromboembolic pu...
CymaBay Therapeutics says it will seek FDA approval for seladelpar for treating adult patients with primary biliary cholangitis after reporting Phase ...
Federal Register notices: FDA issues two priority review vouchers to sponsors whose recent product approvals met the criteria (rare pediatric disease ...
FDA says it is working with the CDC to investigate cases of TB associated with a bone matrix product.
Federal Register notice: FDA releases three draft guidances that are intended to improve the predictability, consistency, and transparency of the 510(...
Federal Register notice: FDA announces a 10/31 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to review a Vertex Pharmaceuticals BLA ...
