The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024
If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy
The surgeons were able to remove the entire breast while preserving the nipple through tiny hidden incisions
Combination shows consistent benefit across prespecified post-progression outcomes
To accelerate the development of next-generation radioconjugates to treat cancer
Ukrainian marketing approvals for paclitaxel, oxaliplatin and irinotecan mark a significant milestone in the company’s global expansion strategy
The validations confirm the completion of the applications and commence the scientific review process
About 75% of all primary liver cancers in adults are HCC and up to 30% of HCC patients are eligible for embolisation
Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival
Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy
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