Combination Therapies: Incentives Needed To Encourage Labeling Across Products
If sponsors will not work together to ensure that labeling for all drugs used as part of a combination regimen are in sync, then US FDA should take measures to streamline process and Congress may need to step in with carrot or stick incentives, a multi-stakeholder group suggests.
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US FDA encouraging developers to embrace cross-labeling rather than continue separate development of proprietary PD-1 agents, but agency sounds eager for any other good ideas to pare back the number of checkpoint inhibitors in development.
Sarepta’s DMD Gene Therapy Adcomm Likely To Focus On Dystrophin As A Surrogate Endpoint
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Genentech’s Polivy Gets US FDA Panel Nod For First-Line Use In Large B-Cell Lymphoma
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