Keeping Track: First COVID Vaccine BLA Kicks Off; Oncology Submissions From Hutchmed, Takeda And Shorla
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Five novel agents have user fee goal dates in the coming month, the Pink Sheet’s US FDA Performance Tracker shows.
The swift rise of China’s oncology R&D has put at least four novel applications before FDA with pivotal data generated only in China.
Congenital athymia treatment Rethymic (RVT-802) is still under FDA review, with an 8 October user fee goal date, but FDA announced the regenerative medicine product had earned a rare pediatric disease priority review voucher; agency says the notice was published in error and will be withdrawn.