[ Price : $8.95]
FDA approves a Lupin BLA for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar to Genentech's blockbuster eye drug Lucen...[ Price : $8.95]
FDA releases a draft guidance outlining post-approval responsibilities facing manufacturers of generic drugs, highlighting require...[ Price : $8.95]
Radiopharmaceutical drug manufacturers say they need more consistency from FDA in inspections and regulatory operations.[ Price : $8.95]
The U.S. Supreme Court hands a victory to Hikma Pharmaceuticals in a closely watched case testing the patent risks of FDA-approved...[ Price : $8.95]
FDA posts a guidance outlining its intent to exempt several low-risk, unclassified medical devices from premarket notification req...[ Price : $8.95]
A Friends of Cancer Research white paper recommends three ways the FDA Biomarker Qualification Program could be improved.[ Price : $8.95]
U.S. House lawmakers introduce bipartisan legislation aimed at expanding federal scrutiny of U.S. investments in China's biotechno...[ Price : $8.95]
Former FDAers Richard Pazdur and Nicole Gormley promote ways to restructure the agency so it can be more independent and successfu...