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(HealthDay)—Mavyret (glecaprevir and pibrentasvir) tablets are now approved to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17 years, the U.S. Food and Drug Administration announced yesterday. The FDA approved Mavyret to treat HCV in adults in 2017. This new approval marks the first treatment option for all HCV […]
(HealthDay)—The U.S. Food and Drug Administration has given its blessing to the first immunotherapy regimen for breast cancer. The combination of immunotherapy (Tecentriq) and chemotherapy (Abraxane) was given accelerated approval for triple-negative breast cancer that is locally advanced or has metastasized, cannot be surgically removed, and is programmed death-ligand 1-postive, CNN reported. A study published […]
MONDAY, Oct. 1, 2018 — Arikayce (amikacin liposome inhalation suspension) has been approved by the U.S. Food and Drug Administration to treat lung disease caused by Mycobacterium avium complex (MAC) bacteria among patients who do not respond to conventional therapies, the FDA said in a news release. MAC bacteria are commonly found in water and […]
THURSDAY, Aug. 16, 2018 — The first generic version of the EpiPen was approved by the U.S. Food and Drug Administration on Thursday, paving the way for more affordable versions of the lifesaving allergy emergency medication. Though other injectors are available, this drug, made by Teva Pharmaceuticals USA, is the first the FDA has said […]