drug approvals

positive negative up down good bad mixed

FDA single-trial guidance calls for the good, bad and ugly data

Biopharmas looking to submit a drug for approval to the FDA based on just one clinical trial better be thorough in the data they include—good and bad.

Annalee Armstrong Sep 19, 2023 10:15am

Illustration of Amyloid plaques around neurons alongside healthy neurons

The FDA's decision on aducanumab will drag down science

Jun 9, 2021 8:45am

Aducanumab approval appears to boost Biogen's AD competitors

Jun 7, 2021 1:00pm

New commish, COVID-19, bad comms hitting FDA speedy approvals

Aug 26, 2020 8:40am

EMA starts accelerated review of Gilead's remdesivir

May 1, 2020 6:00am

Giuliani-promoted COVID-19 therapy nabs FDA speedy start

Apr 2, 2020 9:00am