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
Study efficacy measures will include the expression of dystrophin protein and motor function.
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
Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.
Bourgoin early development hub broadens offerings for oral solid dose formulations
New York State’s largest health system adopts Philips patient monitoring platform to drive integration and innovation for a better patient and staff experience and improved outcomes
First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients
NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China
Cooperative agreement with U.S. Government to advance U.S. biopharma industry and ensure pandemic preparedness
The facility is over 79,000 square feet and is equipped with packaging lines
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