Generic Drugs Forum (GDF) 2024

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access – Day Two – Part OnePediatric Excipient Evaluation: Bioequivalence (BE) PerspectiveRecording and SlidesYang Lu, PhDSenior Staff FellowDB III | OB | OGD | CDERGDSA-BE: Modernizing...

ROCTAVIAN

STN:125720Proper Name: valoctocogene roxaparvovec-rvoxTradename: ROCTAVIANManufacturer: BioMarin Pharmaceutical Inc.Indication:Indicated for the treatment of adults with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity

FDA approves cemiplimab-rwlc

On October 8, 2025, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc.) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.Full...