Takeda hopes for good news on fruquintinib and TAK-755, while Bristol and SpringWorks share a goal date for their breakthrough-designated cancer treatments.

Only two breakthrough-designated novel agents remain on the US FDA drugs center’s 2023 user fee calendar, while CBER stacks up on vaccines and gene therapies under both BTD and RMAT programs.

Pink Sheet analysis finds big jump in the share of novel approvals that received PDUFA extensions, largely driven by clinical and safety data submissions.

CDC Advisory Committee on Immunization Practices prepares for expected US FDA approvals of new vaccines to prevent respiratory syncytial virus in older adults, chikungunya and dengue and clarified recommendations for high-valent pneumococcal vaccines.