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...
In an opern letter to president Trump, rare disease advocates urge him to push FDA to accelerate approvals for treatments targeting fatal genetic diso...
Regeneron Pharmaceuticals says its Phase 3 trial evaluating the experimental immunotherapy combination of fianlimab and cemiplimab in advanced melanom...
