FDA Review posts product approval summaries for the week ending 11/26/2021.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Immunomedics breast cancer therapy Trodelvy.
FDA warns Minneapolis-based Smiths Medical about Medical Device Reporting and Quality System violations in its work as a specification developer and m...
FDA schedules a 12/14 Webinar on the medical device de novo classification process and its guidance document updates.
The Justice Department says a French national has been charged with making false statements to FDA to fraudulently obtain control of the weight-loss d...
FDA grants Pear Therapeutics a breakthrough device designation for its reSET-A PDT (Prescription Digital Therapeutic) product candidate designed for t...
FDA warns Scottsdale, AZ-based Surgenex about CGMP and other violations in its production and distribution of cellular products for allogenic use.