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The drug was approved via the FDA’s Animal Rule, which accepts findings from animal studies when clinical studies in humans are unable to take place. Read More
Despite an unconvinced advisory committee panel and accusations that the FDA worked too closely with Biogen on its Alzheimer’s drug aducanumab, the agency on Monday moved to OK the drug under accelerated approval in a long-awaited decision for patients with the degenerative neurological illness. Read More
Regeneron Pharmaceuticals has received an updated Emergency Use Authorization (EUA) from the FDA for a lower dosage of its COVID-19 antibody cocktail, REGEN-COV (casirivimab/imdevimab). Read More
Scynexis has secured FDA approval for Brexafemme (ibrexafungerp) as an oral treatment for vaginal yeast infections, making it the first FDA-approved drug in a novel antifungal class in more than 20 years, according to the company. Read More
Verily has enlisted Amy Abernethy, the FDA’s former principal deputy commissioner and acting chief information officer, as its next president of clinical research. Read More
The Opdivo-Yervoy combination has received previous EU marketing authorizations for other advanced cancers, including nonsmall-cell lung cancer, melanoma and renal cell carcinoma. Read More