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Agency directs Sprout to disseminate corrective messages about the risks associated with the female sexual dysfunction pill. Sprout previously challenged FDA’s alcohol labeling requirements.
Gene Therapies: US FDA Clarity Needed On ‘Sameness’ Determinations For Products From Same Vector Class
Agency also should better define, and provide examples of, the types of minor differences and additional features that would affect orphan drug designation and exclusivity determinations, industry sponsors say in comments on January draft guidance.
US FDA authorization will further boost already-high demand for plasma from individuals recovered from COVID-19 and increase competition for donors, NYU’s Arthur Caplan predicts, but CoVIg-19 Plasma Alliance and Emergent BioSolutions say they do not expect EUA to impact either product supply or enrollment in upcoming randomized trials of their H-Ig products.
Private Company Edition: Several drug developers targeting neurological diseases raised venture capital recently. In addition to Nura Bio, Encoded Therapeutics revealed a $135m series D round. Also, Longwood closed a $170m fund and Flagship launched Omega Therapeutics with $85m.
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