Keeping Track: Axsome’s Auvelity Survives Long Review; Bluebird’s Zynteglo Cleared For Liftoff; Omeros Appeals CRL
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Keeping Track: After COVID Delays, US FDA Approvals At Last For Daxxify, Rolvedon (But A CRL For Alvotech)
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US FDA Quashes Citizen Petition Against Bluebird’s Zynteglo That Cited Patent, Safety Concerns
San Rocco, whose potential rival gene therapy for thalassemia is in preclinical development, had wanted FDA to delay approval of bluebird’s BLA until resolution of a patent case and a ‘careful investigation’ of Zynteglo’s risks.