Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial and unmet need for additional therapeutic options for certain types of melanoma
First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients
For the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma
With this additional route of administration, the MMRV Family now joins other routinely recommended vaccines that can be administered intramuscularly
Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.
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
Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US
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