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Accelerated Approval Process Is Not Without Risk: Placing Recent FDA Action in Context | Troutman Pepper

On February 23, the Food and Drug Administration (FDA) withdrew approval of Pepaxto (melphalan flufenamide), a drug that it had previously granted accelerated approval for treatment of.

Intercept pharms incDrug administrationHemispherix biopharma incNew drug applicationDrug omnibus report actNot withdraw accelerated approval mostMalignant hematologicalDraft guidanceDemonstrating substantial evidenceHuman drugBiological productsPeter marksFinal decisionWithdraw approvalProviding submissionsNon electronic format

FDA withdraws approval of cancer drug Pepaxto

FDA withdraws approval of cancer drug Pepaxto
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Peter marksDrug administrationOncologic drugs advisory committeeBiologics evaluationResearch directorFederal registerDrug omnibus report act