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FDA approves new leukemia drug
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare type of leukemia, the agency said Thursday.
The FDA approved South San Francisco, Calif.-based Talon Therapeutics' Marqibo (vincristine sulfate liposome), an injectable drug for Philadelphia chromosome-negative acute lymphoblasic leukemia, or Ph-negative ALL.
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FDA panel backs Pfizer drug for rare genetic disease
NEW YORK — An experimental drug made by Pfizer for a rare and fatal neurodegenerative disease got a favorable vote from a Food and Drug Administration expert panel.
The FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 13-4 that the drug tafamidis meglumine would provide certain clinical benefits to patients with transthyretin familial amyloid polyneuropathy, or TTR-FAP, a hereditary disease that affects about 8,000 people worldwide. The FDA is not required to follow the recommendations of FDA advisory committees, but usually does.