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FDA blocks approval of Regeneron's blood cancer drug

FDA blocks approval of Regeneron's blood cancer drug
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Robert Califf , Peter Marks , Biologics Evaluation , Research Director Peter Marks , Fierce Biotech ,

FDA Withdraws Approval of Pepaxto for Multiple Myeloma

The FDA has made the final decision to withdraw the approval of Pepaxto (melphalan flufenamide) for multiple myeloma. ....

Peter Marks , Drug Administration , Biologics Evaluation , Research Director Peter Marks ,

USDA under pressure to liberalize regulation of human gene-therapies and gene-editing, so US doesn't fall further behind other countries

Worries about heritable genetic modifications are subsiding and sponsors should consider the US for regulatory advice and clinical trials. ....

Peter Marks , Drug Administration , Biologics Evaluation , Research Director Peter Marks , Pink Sheet ,