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- FDA issues complete response letter rejecting ITM Isotope's radiopharma therapy over manufacturing concernsFDA sent a complete response letter rejecting the NDA for ITM Isotope's investigational radiopharmaceutical, citing manufacturing and third-party facility issues. The agency said there were no con…
- Scholar Rock pulls Indiana fill-finish plant from SMA therapy filing after FDA flags violationsScholar Rock has removed Novo Nordisk's former Catalent fill‑finish facility in Bloomington, Indiana, from its regulatory filing for a spinal muscular atrophy therapy after the FDA classified the p…