Prometheus Biosciences’ comprehensive data set enables target discovery and precision medicine approach in inflammation and immunology
mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of recurrence or death by 44% compared to KEYTRUDA alone in stage III/IV melanoma patients
Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression
First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients
With this additional route of administration, the MMRV Family now joins other routinely recommended vaccines that can be administered intramuscularly
AstraZeneca and Merck are committed to working with the FDA to bring LYNPARZA in combination with abi/pred to patients diagnosed with mCRPC.
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial
The safety profile of LAGEVRIO in this trial was generally consistent with that observed in previously reported clinical studies
Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival
FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients
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