Accelerated cancer drug approvals yield modest survival gains at significant Medicare cost

Early access to new cancer drugs, granted accelerated approval by the U.S. Food and Drug Administration (FDA), has provided mixed benefits for patients while costing Medicare billions of dollars, ...
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DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old

DBV and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis COMFORT Toddlers study ...
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Sangamo targets Q1 2026 BLA submission for Fabry gene therapy as FDA affirms accelerated pathway

CEO Alexander Macrae highlighted continued advancement of the clinical and preclinical pipeline, with a focus on managing cash resources. Macrae stated, "In September, we presented promising detailed ...