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Exondys 51

FDA
Pharma

OIG says FDA accelerated approval program needs adjustments

The OIG recommended tweaks to the FDA’s accelerated approval pathway but concluded that the controversial nod for Biogen's Aduhelm was an outlier.
Kevin Dunleavy Jan 16, 2025 3:45pm
priority review voucher

Sarepta pawns off PRV for $102M to unidentified buyer

Jul 6, 2023 8:10am
Wheelchair

NS Pharma Duchenne drug wins speedy FDA nod to challenge Sarepta

Aug 13, 2020 11:34am
Green traffic light

Sarepta's new DMD drug wins FDA nod in surprising reversal

Dec 13, 2019 10:03am
Gavel on top of cash

Sarepta's Exondys therapy not cost-effective for patients: ICER

May 23, 2019 12:06pm
EUDRA

CHMP endorses Lilly's CGRP Emgality, Spark's Luxturna and more

Sep 21, 2018 11:58am

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