FDA publishes a draft guidance recommending medical device design outputs essential for establishing and assessing drug delivery performance in device...
FDA says Philips Respironics has updated use instructions for three BiPAP ventilators in a Class 1 recall.
The Coalition for Sensible Safeguards calls on Congress to enact Chevron deference into law following a Supreme Court decision gutting the 40-year-old...
Abbott Medical recalls (Class 1) its HeartMate System Monitor due to atypical behavior of the System Monitor screen.
FDA releases the form FDA-483 with four observations from an inspection at the Brookfield, CT-based Brookfield Medical/Surgical Supplies outsourcing f...
FDA issues Rocket Pharmaceuticals a complete response letter on its BLA for gene therapy Kresladi (marnetegragene autotemcel; marne-cel) for treating ...
FDA approves a Shorla Oncology NDA for Tepylute (thiotepa), a ready-to-dilute formulation for treating breast and ovarian cancer.
Johnson & Johnson reports positive data from its Phase 3 Vivacity-MG3 study of nipocalimab in patients with generalized myasthenia gravis.
