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The FDA has approved Pfizer’s Prevnar 20 conjugate vaccine, which prevents invasive disease and pneumonia from 20 different strains of streptococcus. Read More
The FDA has granted Fast Track designation to BerGenBio’s Bemcentinib in combination with an anti-PD-(L)1 therapy for patients with AXL-positive advanced or metastatic nonsmall-cell lung cancer (NSCLC). Read More
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