FDA is permitting Covid-19 vaccine makers to submit mouse data to expedite authorization of their omicron-protecting vaccine boosters, a move some see...
Federal Register final rule: FDA establishes a regulatory category for over-the-counter hearing aids and making related amendments to update the regul...
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...
