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Real-world Evidence (RWE) for Regulatory and Reimbursement Decisions
We have previously discussed the potential roles of real-world data (RWD) and real-world evidence (RWE) for drug access. However, the precise roles of RWE...
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FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for...
KENILWORTH, N.J.--(BUSINESS WIRE)--FDA Grants Priority Review to Merck’s Supplemental BLA for KEYTRUDA® (pembrolizumab) with Inlyta® (axitinib) as First Line Treatment for Advanced RCC
U.S. proposes Medicare coverage for CAR-T cancer therapies
The U.S. Centers for Medicare & Medicaid Services (CMS) on Friday proposed Medicare coverage of approved CAR-T cell therapies that use the patient's immune system to fight cancer.
