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$VCNX Live In Play®richardred, published August 10, 2021
Updated: 10-Aug-21 06:47 ET
MRK: Merck application accepted by FDA for KEYTRUDA as single agent for certain patients with MSI-H/dMMR advanced endometrial carcinoma (75.32)
FDA has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck's anti-PD-1 therapy, as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of March 28, 2022.
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