FDA warns Chinas Hangzhou Yiqi Biotechnology Co. about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
FDA publishes frequently asked questions covering eligibility, statement of interest, and selection of participants for the TEMPO digital health pilot...
FDA warns Chinas Harbin Jixianglong Biotech about CGMP deviations and other violations in its manufacturing of active pharmaceutical ingredients.
A Stanford Law School Center for the Law and Biosciences fellow says policymakers should consider the growth in breakthrough medical devices cleared t...
FDA grants Bayer a priority review for its NDA for asundexian, an investigational oral Factor XIa inhibitor designed to reduce the risk of recurrent s...
The U.S. Supreme Court declines to hear a series of pharmaceutical industry challenges to the governments Medicare drug price negotiation program.
FDA faces renewed scrutiny of an internal FDA analysis of pediatric deaths reported after Covid-19 vaccination, following the release of documents by ...
FDA grants Bayer a priority review for its supplemental NDA for Hyrnuo (sevabertinib) as a first-line treatment for patients with HER2-mutant non-smal...
