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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 · 1d 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
- Vir Biotechnology reports positive results for hepatitis D combo in first pivotal trialVir Biotechnology announced that its chronic hepatitis D treatment met its primary goal in the first of three late‑stage studies. The trial evaluated a once‑monthly combination therapy that include…