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Regulatory Assessment
Pharma
Biogen vows to contest EMA snub of Aduhelm
The EMA has officially adopted a negative opinion on Biogen and Eisai’s application for Aduhelm in early-stage Alzheimer’s disease.
Angus Liu
Dec 17, 2021 10:50am
FDA makes pitstop on its roadmap for pandemic-era oversight
Nov 23, 2021 3:50pm
FDA rejects Perrigo copy of Teva's ProAir inhaler for third time
May 14, 2018 12:00pm
GSK's Juluca, Amgen's Repatha and more score EU backing
Mar 23, 2018 11:40am
FDA delays verdict on Allergan's Esmya
Mar 1, 2018 11:34am
Mitsubishi Tanabe eyes 2017 U.S. approval for edaravone in ALS
Sep 1, 2016 7:56am
