An independent assessment of the FDA Total Product Lifecycle Advisory Program pilot finds it met its objectives exceptionally well and has several opp...
FDA approves the first at-home, prescription-only brain-stimulation device to treat major depressive disorder.
Rep. Jan Schakowsky and Sen. Dick Durbin reintroduce their Medical Device Recall Improvement Act to improve medical device recall communications betwe...
Serina Therapeutics files a complete response to an FDA clinical hold on SER-252, the companys lead investigational therapy for advanced Parkinsons di...
FDA weighs changes to a long-standing labeling rule for dietary supplements and will temporarily exercise enforcement discretion on certain disclaimer...
FDA warns Brookhaven, GA-based Ponya Therapeutics about violations of regulations governing human cells, tissues, and cellular and tissue-based produc...
FDA clears a Lumos Labs 510(k) for LumosityRx, a prescription digital therapeutic intended to improve attention in adults with attention-deficit/hyper...
Roche reports positive Phase 3 lidERA trial results for its giredestrant selective estrogen receptor degrader endocrine therapy in some breast cancer ...
