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The FDA deemed the data submitted for children and teens “not sufficient to obtain approval of an indication in the pediatric population at this time,” Sanofi said. Read More
The EU has approved Sanofi’s Aubagio (teriflunomide) for use in children and adolescents with multiple sclerosis — just days after the FDA issued the company a Complete Response Letter regarding its supplemental New Drug Application (sNDA) for Aubagio, rejecting its use in children and adolescents ages 10 to 17 years and requesting more pediatric data. Read More
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