Pfizer’s Duavee Approved For Hot Flashes, Osteoporosis Prevention
This article was originally published in The Pink Sheet Daily
FDA cleared the single pill combining conjugated estrogens with bazedoxifene, a novel selective estrogen receptor modulator, for two indications but issued a “complete response” letter for use in vulvar and vaginal atrophy.
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'Limited activities related to user fee funded programs' will continue if Congress does not pass a short-term funding measure by Oct. 1.
Europe’s top medicines advisory panel, the CHMP, also recommended for approval Clinuvel’s Scenesse for severe intolerance to sunlight, Pfizer’s new combination menopausal symptom therapy Duavive, and Baxter’s new hemophilia B therapy Rixubis.
As normal operations – and normal budget worries – resume, the agency has some meetings to reschedule.