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
Febuxostat Tablets (RLD Uloric) had estimated annual sales of US$ 27 million in the U.S. (IQVIA MAT November 2023)
The PAI was conducted for two drug product applications (ANDAs) filed from this facility
Bayer has granted the non-exclusive rights to Sun Pharma to market and distribute a second brand of Finerenone under the brand name Lyvelsa
Sonoma will manufacture Ocudox by Avenova with packaging similar to NovaBay’s Avenova products
Keytruda is the first and only anti-PD-1 therapy approved in combination with chemoradiotherapy for these patients
Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy
TALZENNA is the first and only PARP inhibitor approved in combination with standard of care XTANDI for mCRPC patients in the European Union
This agreement includes upfront and milestone payments with a combined potential value of over $500m and sales royalties.
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