[ Price : $8.95]
FDA issues Xspray Pharma a complete response letter for the company's NDA for Nilopki, an improved formulation of nilotinib design...[ Price : $8.95]
FDA says its breakthrough devices program has surpassed 1,280 designations since its launch, highlighting the growing use of the e...[ 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FDA releases a draft guidance outlining post-approval responsibilities facing manufacturers of generic drugs, highlighting require...[ Price : $8.95]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.