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drug approvals
Biotech
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
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