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Regeneron says it will submit a BLA to FDA this year for its linvoseltamab multiple myeloma drug based on successful Phase 1/2 tri...[ Price : $8.95]
Reps. Eshoo and McCaul introduce bipartisan legislation to strengthen pediatric drug development.[ Price : $8.95]
Zydus Pharmaceuticals asks FDA to take multiple actions against BPI Labs unapproved methylene blue injection product.[ Price : $8.95]
Bausch & Lomb asks FDA to impose conditions on any ANDAs for a generic form of its macular edema drug Xipere.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Verification Systems Under the Drug Supply Chain Security A...[ Price : $8.95]
Merck stops a Phase 3 KEYLYNK-008 trial evaluating anti-PD-1 therapy Keytruda (pembrolizumab) in combination with maintenance Lynp...[ Price : $8.95]
Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for QED Therapeutics Truse...[ Price : $8.95]
ProPublica and the Pittsburgh Post-Gazette take aim at alleged FDA failures to properly manage a timely response to reports of pro...