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FDA slams the door in Humanigen’s face, rejects emergency use green light, wants more data

September 9, 2021


After riding high in 2021 on some broadly positive COVID data and high hopes for a speedy authorization, Humanigen has come crashing back down to earth.

Early Thursday morning, Humanigen said the FDA has rejected giving the biotech an emergency use authorization (EUA) for its COVID drug hopeful lenzilumab in patients hit with the disease and in hospital. The Californian company had asked the FDA to hand out the EUA for its drug, which it believed could help calm the so-called “cytokine storm” that can hit some COVID patients.

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