FDA's CBER details a framework for sponsors to apply existing CMC, nonclinical, and clinical data to genome-editing-based product development and regulatory filings.
Feliza Mirasol
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Feliza Mirasol is the science editor for BioPharm International.
Articles by Feliza Mirasol
Bristol Myers Squibb and Hengrui Pharma launch a multibillion-dollar collaboration spanning 13 oncology, hematology, and immunology programs to expand global drug development pipelines and accelerate early-stage clinical innovation.
Approval of Biogen's high-dose Spinraza strengthens the company’s lifecycle strategy in SMA, enhancing durability while reinforcing competitive positioning in a rapidly evolving neurology market.
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