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Concerns Mount over Limited Evidence for Accelerated Approvals
January 26th 2022Delays in sponsors providing postapproval evidence of effectiveness for therapies benefitting from streamlined FDA regulatory pathways are generating pressure for further review and reform of the agency’s accelerated approval process.
AstraZeneca’s Tagrisso Accepted for Use in Scotland to Treat EGFR Mutated Advanced Lung Cancer
January 21st 2022AstraZeneca's Tagrisso has been accepted for use as a monotherapy for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations in Scotland.