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...
FDA grants Incyte accelerated approval of its BLA for Zynyz (retifanlimab-dlwr) for treating adults with metastatic or recurrent locally advanced Merk...
The Senate Homeland Security & Governmental Affairs majority staff issues a report recommending six things FDA, Congress, and other stakeholders can d...
