source
- Vir hepatitis D drug succeeds in first pivotal studyA program that’s survived Vir’s pivot away from infectious disease research hit all of its study objectives and appeared more potent than a rival drug also in late-stage development.BioPharma Dive · 4d ago↗ source
- 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 · 4d 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.