[ Price : $8.95]
FDA names CDER Office of Generic Drugs safety and clinical evaluation acting director Iilun Murphy as the next OGD director, repla...[ Price : $8.95]
FDA greenlights commercial production of CAR T cell therapy at a new Bristol Myers Squibb manufacturing site in Devens, MA.[ Price : $8.95]
FDAs Antimicrobial Drugs Advisory Committee votes unanimously that AstraZeneca and Sanofis nirsevimab has a favorable benefit-risk...[ Price : $8.95]
Novartis urges FDA to broaden its proposal on patient preference information beyond medical devices.[ Price : $8.95]
FDA publishes a guidance with specifics about changes to user fees imposed under the GDUFA 3 reauthorization in 2022.[ Price : $8.95]
FDA approves a Novaliq NDA for Vevye (cyclosporine ophthalmic solution) 0.1% for treating the signs and symptoms of dry eye diseas...[ Price : $8.95]
Two SheppardMullin attorneys describe how two recent FDA guidances on pediatric drug development will tighten eligibility for pedi...[ Price : $8.95]
FibroGen says its pamrevlumab failed to meet the primary endpoint in treating Duchenne Muscular Dystrophy in a Phase 3 trial.