FDA approves a Lupin BLA for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar to Genentech's blockbuster eye drug Lucentis.
FDA releases a draft guidance outlining post-approval responsibilities facing manufacturers of generic drugs, highlighting requirements ranging from a...
Radiopharmaceutical drug manufacturers say they need more consistency from FDA in inspections and regulatory operations.
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.
