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