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In a confirmatory trial, Exkivity did not meet the primary endpoint in treating patients with non-small cell lung cancer with EGFR exon 20 mutations. It will remain available while Takeda works with the FDA on withdrawal timing.

FDA Approves New Pompe Therapy

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The two-component therapy of Pombiliti plus Opfolda to treat adults living with late-onset Pompe disease will have an annual list price of $650,000.

ICER adds a more formal process to evaluate the diversity of clinical trials and an assessment of a product’s impact on patient and caregiver productivity. ICER also plans to evaluate how newer methods — which would consider the change of a drug’s price over time and disease severity — can be applied to its value assessment.