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A manufacturing problem flagged by U.S. regulators has halted a radiopharmaceutical, a cancer therapy that works by delivering radioactive isotopes directly to tumor cells.
The drug's maker, ITM Isotope Technologies Munich SE, had already moved to commercialize it, launching a new division called Lumara Bio last month. The rejection blocks what would have been a new competitor for Novartis.
What the FDA found, and what it means The agency's decision turned on manufacturing deficiencies, not the drug's clinical results. That distinction carries weight.
A company that stumbles on manufacturing has a different corrective path than one whose efficacy data fell short, and that path remains open, in theory. No timeline for resubmission has been reported.
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