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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

ODE I director Ellis Unger chafed at the notion of approving the Duchenne muscular dystrophy drug golodirsen on the same unvalidated surrogate marker, this time in the face of infection and renal toxicity concerns; OND’s Peter Stein granted Sarepta’s appeal while also calling attention to the company’s failure to timely conduct the eteplirsen confirmatory trial.

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

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