FDA Delays Lantheus PET Agent Approval Over Manufacturing Issues

The FDA has delayed approval of a Lantheus PET imaging agent due to manufacturing issues. The specific agent and timeline were not disclosed, potentially postponing its clinical introduction.

• FDA action: approval delayed because of manufacturing deficiencies; no efficacy or safety concerns reported.
• The agent's identity and the revised timeline are not yet public.
• Lantheus has not issued a new expected approval date.

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