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- Biotech firms must adopt global regulatory strategies to commercialize drugs independentlyBiotech developers are increasingly able to fund the pursuit of regulatory approval and commercial launch on their own, rather than selling their assets early. This new option is driven by a reboun…
- FDA releases draft guidance to streamline approval of personalized gene therapiesThe FDA announced a draft guidance aimed at expanding access to gene therapies that target different mutations within the same disease. The proposal outlines an "individualized feature space" that…