Human Drugs
Imaging Drug OKd for Ovarian Cancer Detection
FDA approves an On Target Laboratories NDA for Cytalux (pafolacianine), an imaging drug to assist surgeons in identifying ovarian cancer lesions.
Human Drugs
Mercks Covid Drug has 52% Risk Reduction: FDA
An FDA advisory committee briefing document says Mercks oral antiviral molnupiravir is associated with a relative risk reduction of 52% in hospitaliz...
FDA General
Latest Federal Register Notices
FDA Review posts the Federal register notices for the week ending 11/26/2021.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 11/26/2021.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Federal Register
Regulatory Review Period for Immunomedics Trodelvy
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Immunomedics breast cancer therapy Trodelvy.
Medical Devices
MDR and QS Violations at Smiths Medical
FDA warns Minneapolis-based Smiths Medical about Medical Device Reporting and Quality System violations in its work as a specification developer and m...
Medical Devices
De Novo Classification Rule Webinar
FDA schedules a 12/14 Webinar on the medical device de novo classification process and its guidance document updates.
Human Drugs
Feds Say Frenchman Made False Statements to FDA
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...
Medical Devices
Pear Therapeutics Breakthrough for Alcohol-use App
FDA grants Pear Therapeutics a breakthrough device designation for its reSET-A PDT (Prescription Digital Therapeutic) product candidate designed for t...
