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Stivarga receives expanded approval to include hepatocellular carcinoma
WASHINGTON — The Food and Drug Administration on Thursday expanded the approved use of Stivarga (regorafinib) to include treatment of patients with hepatocellular carcinoma (HCC or liver cancer) who have been previously treated with the drug sorafenib. The drug, manufactured by Bayer HealthCare Pharmaceuticals, is the first FDA-approved treatment for a liver cancer in almost a decade.
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FDA approves first drug for specific form of Batten disease
WASHINGTON — The Food and Drug Administration on Thursday approved Brineura (cerliponase alfa) as a treatment for a specific form of Batten disease. BioMarin Pharmaceuticals’ Brineura is the first FDA-approved treatment to slow loss of walking ability (ambulation) in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase-1 (TPP1) deficiency.