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Accelerated Approval: Avastin, Makena Bookend A Watershed Decade For US FDA’s Expedited Pathway

Executive Summary

Pink Sheet interactive timeline looks at key regulatory, policy and legislative developments impacting the accelerated approval pathway over the last 10 years.

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With Sarepta’s Vyondys, US FDA Staff Saw Opportunity To Right Perceived Wrongs With Exondys

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Makena Withdrawal Dilemma: Advisory Cmte. Split Offers No Clear Direction For US FDA

Nine of 16 advisory committee members favored withdrawal of AMAG’s preterm birth drug because substantial evidence of efficacy is lacking and clinical benefit has not been confirmed; seven panelists favored keeping the drug on the market but requiring a new trial.

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