CDRH director Jeff Shuren tells an Alliance for Stronger FDA Webinar that cybersecurity is one of the biggest concerns that keeps him up at night.
FDA approves a Cidara Therapeutics and Melinta Therapeutics NDA for Rezzayo (rezafungin for injection) for treating candidemia and invasive candidiasi...
The Federal Trade Commission asks the Delaware federal court to consider four antitrust implications in deciding whether to grant a Supurnus motion to...
FDA issues AbbVie a complete response letter for ABBV-951 (foscarbidopa/foslevodopa) for treating motor fluctuations in adults with advanced Parkinson...
FDA says events involving squamous cell carcinoma in the scar tissue (capsule) that forms around breast implants should be reported to a registry deve...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Shionogi & Co.s Mulpleta (lusutrombopag).
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Amicus Therapeutics Galafold (migalastat).
FDA warns Procter & Gamble (P&G) about unresolved contradictory information in the electronic listing for one of its Nyquil products and the product l...
