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February 25, 2014
08:45 EDTBMYFDA announces approval of Bristol-Myers' lipodystrophy treatment
The FDA announced that it approved Myalept as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy. Because of the risks associated with the development of neutralizing antibodies and lymphoma, Myalept is available only through the Myalept Risk Evaluation and Mitigation Strategy Program, the FDA said. The agency is requiring seven studies for Myalept, including a long-term prospective observational study, of patients treated with the drug. Myalept is marketed by Amylin Pharmaceuticals, which Bristol-Myers acquired in 2012.
News For BMY From The Last 14 Days
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June 26, 2015
08:31 EDTBMYAlexandria Real Estate announces lease with Bristol-Myers in Cambridge
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June 25, 2015
09:34 EDTBMYBristol-Myers expects Waltham site to close in early 2018
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09:32 EDTBMYBristol-Myers opens research site in Cambridge, discontinues virology research
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June 24, 2015
07:29 EDTBMYFDAnews to hold a summit
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