A Prescription Drug User Fee Act target date of May 27, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application ...

Spark Therapeutics has sold a priority review voucher, entitling the holder to a faster six-month FDA drug review, to Ireland’s Jazz Pharmaceuticals for $110m, a fraction of the price these ...

Member FDIC Read our Southwest Rapid Rewards® Priority Credit Card review. The Southwest Rapid Rewards® Priority Credit Card is a perfect fit for serious Southwest fans who can easily maximize ...

Merck & Co. has won U.S. Food and Drug Administration priority review for its application seeking expanded use of its Welireg oral cancer drug in patients with rare tumors that form in and around ...

A Prescription Drug User Fee Act target date of May 26, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug ...

The regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review ... to treat in advanced stages, and current therapeutic options are limited.

Sunvozertinib received FDA priority review for NSCLC with EGFR exon 20 insertion mutations after platinum-based chemotherapy progression. The WU-KONG1 Part B study showed a 53.3% objective response ...

Priority Review is granted by the FDA for treatments ... and long-term quality of life. The current standard of care for this disease includes hormone therapy and chemotherapy, but there are ...

Shares of Replimune Group, Inc. (NASDAQ: NASDAQ:REPL) surged 17% following the announcement that the U.S. Food and Drug ...