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- Update: FDA investigates Novartis' Zolgensma following 9 cases of tumors in treated patientsAfter Novartis confirmed the reports of tumors in patients who have been treated with the spinal muscular atrophy gene therapy, the FDA will determine if any regulatory action is needed for Zolgens…BioSpace · 13h ago↗ source
- Recon: FDA orders new eye risk warnings for Ozempic, Zepbound; FDA launches investigation of Novartis’ Zolgensma after cancer ca...Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.raps · 1d ago↗ source
- Merck and Moderna report 99% manufacturing success and 42% lower recurrence risk for personalized melanoma vaccine in Phase 3 trialMerck and Moderna announced that their personalized mRNA cancer vaccine, combined with Keytruda, was successfully manufactured for 99% of patients enrolled in a large Phase 3 study. The trial, call…