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FDA approves Chemo Research's treatment for Chagas disease
WASHINGTON — Earlier this week the U.S. Food and Drug Administration approved Chemo Research's New Drug Application for benznidazole. This is the first drug ever approved by the FDA to treat Chagas disease.
Benznidazole is an essential medicine for Chagas disease, a parasitic disease that affects an estimated 6 million to 8 million people worldwide. In the United States, an estimated 300,000 people are living with Chagas disease. Previously, it was available through the Centers for Disease Control and Prevention, but was not FDA approved.
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FDA approves first-ever gene therapy treatment for acute lymphoblastic leukemia
SILVER SPRING, Md. — The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases.
The FDA approved Novartis' Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia. Kymriah is the first therapy based on gene transfer approved by the FDA.
