FDA wants more info on Menveo; advisory negative on Dacogen
Swiss drug major Novartis (NOVN: VX) said this morning that it has received a Complete Response letter from the US Food and Drug Administration on its application for the expanded use of Menveo (meningococcal [groups A, C, Y and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine) in infants and toddlers from two months of age. Menveo is already approved in the USA for use in individuals two to 55 years of age.
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