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- FDA proposes streamlined registration rule for hub-and-spoke drug manufacturing networksThe FDA released a proposed rule that would let distributed drug manufacturing facilities using a hub-and-spoke model register as a single establishment. Under current regulations each site must r…
- FDA Grants First Gene-Therapy Approval for Children 2+ with Sickle Cell DiseaseThe U.S. Food and Drug Administration issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged two years and older who have sickle cell disease with recurrent vaso-oc…