Drug Approval | January 23, 2024
EMA grants ODD to GC Biopharma's treatment for Sanfilippo Syndrome
GC1130A has previously achieved notable milestones by securing both RPDD and ODD from the U.S. FDA in January 2023
GC1130A has previously achieved notable milestones by securing both RPDD and ODD from the U.S. FDA in January 2023
Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting
The CVMP recommends the product for approval for the treatment and persistent killing of fleas
Conditional marketing authorization is based on clinically meaningful response rates, duration of response, and safety from the Phase 2 MagnetisMM-3 trial
Accelerating FDA submission and confirming potential to become first approved biologic for this serious disease
Decision on EU marketing authorisation expected for momelotinib by early 2024
XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy in nonmetastatic castration-sensitive prostate cancer
Glenmark will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to commercialize Winlevi in 15 EU countries
The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway
Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial
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