FDA warns Christiansburg, VA-based Avila Herbals about concerns in its work as a clinical investigator of an investigational drug.
Federal Register notice: FDA seeks comments on recommendations by the World Health Organization to impose international manufacturing and distributing...
FDA places a clinical hold against Legend Biotech and its Phase 1 clinical trial for LB1901, an investigational autologous CAR-T cell therapy for trea...
The U.S. Senate votes 50 to 46 to confirm Robert Califf as the next FDA commissioner.
Aspen Tech Policy Hub fellow Daniel Bardenstein says FDA should require medical device manufacturers to meet a baseline of cybersecurity protections.
FDA clears a Casio America 510(k) for the DZ-D100 DermoCamera and the DZ-S50 scope for skin observation by dermatologists.
FDA grants Datar Cancer Genetics a breakthrough device designation for its TriNetra-Prostate blood test to detect early-stage prostate cancer.
Federal Register notice: FDA announces a 3/15 virtual meeting entitled FDA Hiring and Retention Final Assessment and an opportunity for public comment...