Drug Approval | February 23, 2023
Moderna and Merck announce investigational personalized cancer vaccine mRNA-4157/V940
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients
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Data show 37% reduction in risk of disease progression or death in men with metastatic castration-resistant prostate cancer treated with TALZENNA plus XTANDI
Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic, and prostate cancer
Zidavi is recommended by the Infectious Disease Society of America
Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US
SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
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