Valneva USA Inc.
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Latest From Valneva USA Inc.
November US FDA User Fee Calendar: Takeda On Tap; Small Molecules For Cancer
Takeda hopes for good news on fruquintinib and TAK-755, while Bristol and SpringWorks share a goal date for their breakthrough-designated cancer treatments.
Breakthrough Bounceback Looks Unlikely At US FDA’s CDER, But CBER Is Riding Wave Of RMATs
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.
A 3-Month Delay For A Better Label: US FDA User Fee Goal Extensions Are Usually Good News
Pink Sheet analysis finds big jump in the share of novel approvals that received PDUFA extensions, largely driven by clinical and safety data submissions.
As Vaccines Pipeline Gushes, Complex Communication Challenges Loom
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.
Company Information
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Pharmaceuticals
- Vaccines
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Drug Delivery
- Transdermal
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Biotechnology
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Large Molecule
- Antibodies
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Large Molecule
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