Keyword: Food and Drug Administration (FDA)
Jared Gollob, M.D., is joining Kymera Therapeutics, a startup focused on protein degradation.
The FDA approved Biotronik’s stent to seal tears in coronary arteries, making it the first new treatment option in the indication in 17 years.
Regulatory officials put enrollment in the XMT-1522 breast cancer trial on hold in July after learning of the death of a participant.
Acorda’s share price took a one-two punch this week, with the FDA extending review of its drug-device treatment for Parkinson’s disease by 3 months.
The latest Apple Watch includes an FDA-cleared ECG, making it a medical device capable of alerting users to abnormal heart rhythms.
The agency said it has begun implementing three recommendations from HHS to fully integrate cybersecurity requirements into its premarket reviews.
Baxter received FDA clearance for a formulation of its Actifuse synthetic bone graft, deliverable via a prepackaged syringe requiring no preparation.
Xenon Pharmaceuticals is taking a stab at repurposing GlaxoSmithKline's ezogabine for a rare, difficult-to-treat form of pediatric epilepsy.
Sponsors accepted into the four-year pilot will meet twice with the FDA to discuss regulatory approaches to complex trials.
Zimmer Biomet received a warning letter from the FDA about quality violations found at a plant in Warsaw, Indiana.