FDA says it has received 168 reports of deaths in more than 69,000 medical device reports associated with PE-PUR foam degradation in Philips Respironi...
FDA clears a Preceptis Medical 510(k) for expanded indications for its Hummingbird Tympanostomy Tube System for office-based pediatric ear tube proced...
FDA approves the first cell-based gene therapy for treating adult and pediatric patients with beta-thalassemia who require regular red blood cell tran...
Attorney Brynn Stanley outlines provisions in a 2022 FDA draft cybersecurity guidance and how they differ from the 2018 draft it replaced.
Brainstorm Cell Therapeutics says it will submit a BLA for it NurOwn stem cell therapy for treating amyotrophic lateral sclerosis.
FDA commissioner Robert Califf tells FDA Webview his agency is joining with other entities, especially universities, to form a new ecosystem to find s...
Federal Register notice: FDA makes available a final guidance entitled Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplificatio...
Cancer researchers say circulating tumor DNA may be an important tool in clinical development and an early indicator of treatment benefit.
