Tags : receives

Regulatory

Roche’s Xofluza Receives the EC’s Approval for the Treatment of

Shots: The EC has approved Xofluza (baloxavir marboxil) for uncomplicated influenza in patients aged≥12yrs. Additionally, the EC has approved Xofluza for post-exposure prophylaxis of influenza in individuals aged≥12yrs. The approval follows the CHMP’s positive opinion for Xofluza and is based on P-III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies Xofluza is a first-in-class, single-dose oral therapy, reduces […]Read More

Regulatory

Casi and Juventas Cell Therapy’s CNCT19 (CD19 CAR-T) Receives China

Shots: The BT (breakthrough therapy) Designation was based on initial data for ongoing single-arm, open-label, non-randomized, dose-escalation, P-I study for safety and efficacy in B-ALL The BT Designation procedure is under NMPA’s revised Drug Registration Regulation with effect from Jul 1, 2020. It is designed to expedite the development of treatment of diseases with no […]Read More