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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…
- Sanofi faces shortage of two Pompe disease drugs after FDA flags manufacturing issuesSanofi has reported a shortage of two medicines used to treat Pompe disease. The shortage emerged after the U.S. Food and Drug Administration issued a warning about manufacturing problems at the co…