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The FDA has denied ITM Isotopes Techn | The FDA has denied ITM Isotopes Technologies’ lead pipeline candidate for a rare group of tumors due to qualms over the drug’s manufacturing.
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The FDA rejected ITM's radiopharmaceutical for neuroendocrine tumors because of manufacturing issues, delaying a potential…

From Indiana to Iceland, the FDA this week disclosed concerns raised during recent visits to a pair of manufacturing sites with…

The FDA has rejected a radiopharmaceutical therapy due to manufacturing issues, halting what would have been a competitor for…

The FDA has paused a controversial policy of releasing letters describing its rationale for rejecting drugs, Fierce Biotech has…

Merck & Co.’s extensive clinical development scheme for its TROP2 antibody-drug conjugate (ADC) sac-TMT already

Reporting a new miss in one indication, Karyopharm Therapeutics is plowing ahead with plans to advance its XPO1 inhibitor Xpovio…