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...
Pharmaceutical Research and Manufacturers of America tells the White House Office of Science and Technology Policy its three suggestions for enhancing...
