The U.S. Supreme Court hands a victory to Hikma Pharmaceuticals in a closely watched case testing the patent risks of FDA-approved "skinny label" gene...
FDA posts a guidance outlining its intent to exempt several low-risk, unclassified medical devices from premarket notification requirements.
A Friends of Cancer Research white paper recommends three ways the FDA Biomarker Qualification Program could be improved.
U.S. House lawmakers introduce bipartisan legislation aimed at expanding federal scrutiny of U.S. investments in China's biotechnology sector, arguing...
Former FDAers Richard Pazdur and Nicole Gormley promote ways to restructure the agency so it can be more independent and successful.
FDA has accepted a Letter of Intent for the first in silico artificial intelligence-driven digital liver model for predicting drug-induced liver injur...
FDA accepts for priority review a Roche NDA for giredestrant, an investigational oral endocrine therapy for patients with early-stage estrogen recepto...
FDA issues an untitled letter to QOL Medical, alleging that promotional emails for its rare-disease therapy Sucraid (sacrosidase) Oral Solution were f...
