Enzyvant’s Path From Complete Response Letter To FDA Approval For Rethymic Included CMC Revamp
Two-year journey after CRL did not start with a meeting with US FDA, but rather a ‘pause’ to better understand agency’s perspective, execs say. Firm would later develop a roadmap with FDA to overcome manufacturing issues for the the first tissue-based therapeutic approved by the agency.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Congenital athymia treatment Rethymic (RVT-802) is still under FDA review, with an 8 October user fee goal date, but FDA announced the regenerative medicine product had earned a rare pediatric disease priority review voucher; agency says the notice was published in error and will be withdrawn.
Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.