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- FDA rejects ITM-11 radiopharmaceutical over manufacturing flaws, halting rival to Novartis therapyThe U.S. Food and Drug Administration issued a rejection letter for ITM-11, a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich, citing manufacturing problems that prevent ap…
- Sionna’s Phase 2a CF trial fails, shares plunge as Vertex’s Trikafta remains standard of careSionna Therapeutics announced that its Phase 2a cystic fibrosis trial of the NBD1 stabilizer SION-719 did not meet its primary endpoint, sending the company’s stock down more than 90% in pre‑market…