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- Novocure's Optune Mya device denied FDA approval over efficacy concernsNovocure received a "not approvable" letter from the FDA for its Optune Mya system, which was being evaluated for patients with brain metastases from non‑small cell lung cancer after stereotactic r…
- Experts urge pharma firms to build regulatory intelligence before laws take effectRegulatory specialists advise companies not to wait for legislation to be finalized before creating a regulatory intelligence framework. They argue that early preparation helps firms stay ahead of…