Topic: Genzyme Corporation

U.S. panel rejects Genzyme leukemia drug study

Reuters US Online Report Health News - 372 days ago
SILVER SPRING, Maryland (Reuters) - Genzyme Corp should run a new study before the company can win approval to promote a pediatric leukemia drug for older adults with an aggressive blood cancer, a U.S. advisory panel said on Tuesday. In a 9-3 ...
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FDA panel wants more data on Genzyme cancer drug

AP Features - 373 days ago
A panel of cancer experts has issued a negative review of a leukemia drug from Genzyme, saying more data is needed to establish its safety and efficacy for older patients. The Food and Drug Administration's oncology panel voted 9-3 Tuesday that Cambridge, ...
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FDA: problems with Genzyme study of leukemia drug

AP News - 377 days ago
FDA cites shortcomings with Genzyme study of leukemia drug for frail, elderly patientsFederal regulators on Friday questioned whether Genzyme's leukemia drug Clolar should be approved for older patients based on limited studies conducted by the biotech drugmaker. Cambridge, Mass.-based Genzyme has asked ...
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