Go or no go? PDUFA resolutions eyed for J&J and Amryt

Several projects with delayed Pdufa decisions should finally see outcomes next month, including J&J/Legend's ciltacabtagene autoleucel and Amryt’s Oleogel-S10. Immunocore, however, was able to grasp an early approval today for its immunotherapy tebentafusp, now called Kimmtrak, nearly a month before its February Pdufa decision.

One of the most important regulatory discussions in February will come from a panel meeting on Lilly and Innovent’s Tyvyt. The adcom could indicate whether data generated in China can back US approval.