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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.
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PhRMA names new chief medical officer, EVP
WASHINGTON — The Pharmaceutical Research and Manufacturers of America on Wednesday announced Richard Moscicki will join the organization as chief medical officer and EVP. He will lead the organization's science and regulatory advocacy efforts beginning in early October 2017.