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...
Roche and Eli Lilly collaborate to develop Roches Elecsys Amyloid Plasma Panel, a blood test designed for making earlier diagnoses of Alzheimers disea...
The CBER FY 2022 biological product deviation reporting annual summary says there was a 3% increase in reports submitted over FY 2021.
A new University of Colorado Boulder study points to the need for FDA to work harder to follow and consider further regulating social media micro-infl...
