FDA Decision Alerts

Our FDA Decision Alerts summarize examples in which RWE was included in the submission package for new drugs and biologics. We’ll share updates to this library as the FDA makes approval documents available—and we invite you to subscribe to these alerts below.

October 16, 2020

CDER-Approved NDA for KOSELUGO™ (selumetinib)

Christina Purpura and Elizabeth Dabrowski
September 9, 2020
August 14, 2020

CDER-Approved NDA for TAZVERIK™ (tazemetostat)

Christina Purpura and Mandy Patrick
July 23, 2020

CDER-Approved NDA for ONGENTYS® (opicapone)

Nick Honig and Shannon Reynolds
July 23, 2020
April 21, 2020

CBER-Approved BLA for ZOLGENSMA (onasemnogene abeparvovec-xioi)

Nick Honig, Christina Purpura, and Liz Garry
April 20, 2020
April 20, 2020
April 20, 2020
April 20, 2020


Christina Purpura and Liz Garry
April 20, 2020

CDER-Approved NDA for EGATEN™ (triclabendazole)

Christina Purpura and Tony Louder
April 20, 2020

The Evidence Digest and FDA Decision Alerts

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