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The FDA has declined to authorize Bharat Biotech’s COVID-19 vaccine, Covaxin, for emergency use, prompting the Indian drugmaker’s U.S. partner, Ocugen, to instead seek a full approval of the shot through a Biologics License Application (BLA). Read More
The company is “confident” in the late-stage study results and looks forward to continued discussions with the FDA, said Steven Stein, Incyte’s chief medical officer. Read More
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