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FDA delays action on Salix drug
RALEIGH, N.C. — The Food and Drug Administration will not decide whether to approve a drug for diarrhea in HIV patients as it continues to review the regulatory approval application for it, the drug's manufacturer said.
Salix Pharmaceuticals said the FDA was still reviewing its application for crofelemer in the 125-mg strength. The agency was originally expected to take action on the drug Wednesday. Crofelemer is meant for treating noninfectious diarrhea in HIV and AIDS patients taking antiretroviral therapy.
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FDA approves new drug for rare leukemia
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare blood and marrow cancer that affects older adults, the agency said Tuesday.
The FDA announced the approval of Pfizer's Bosulif (bosutinib) for chronic myelogenous leukemia, or CML. According to the FDA, about 5,430 men and women will be diagnosed with CML this year.
The drug is designed for patients with chronic, accelerated or blast-phase Philadelphia chromosome-positive CML, who can't tolerate other therapies or for whom those therapies don't work.