Fierce Pharma
Fierce Biotech
Fierce Healthcare
Fierce Life Sciences Events
Advertise
About Us
Pharma
Vaccines
Asia
Cell & Gene Therapy
Drug Delivery
Executives
Manufacturing
Facilities
Recalls
Warning Letters
Marketing
Special Reports
Fierce 50
Special Report
Awards Gala
Resources
Podcasts
Fierce Events
Industry Events
Webinars
Whitepapers
Survey
Events
Subscribe
Subscribe
Pharma
Vaccines
Asia
Cell & Gene Therapy
Drug Delivery
Executives
Manufacturing
Facilities
Recalls
Warning Letters
Marketing
Special Reports
Fierce 50
Special Report
Awards Gala
Resources
Podcasts
Fierce Events
Industry Events
Webinars
Whitepapers
Survey
Events
Subscribe
Fierce Pharma
Fierce Biotech
Fierce Healthcare
Fierce Life Sciences Events
Advertise
About Us
Exondys 51
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
Sarepta pawns off PRV for $102M to unidentified buyer
Jul 6, 2023 8:10am
NS Pharma Duchenne drug wins speedy FDA nod to challenge Sarepta
Aug 13, 2020 11:34am
Sarepta's new DMD drug wins FDA nod in surprising reversal
Dec 13, 2019 10:03am
Sarepta's Exondys therapy not cost-effective for patients: ICER
May 23, 2019 12:06pm
CHMP endorses Lilly's CGRP Emgality, Spark's Luxturna and more
Sep 21, 2018 11:58am