Tag: Food & Drug Administration
FDA Cites ‘Significant Deviations’ at Florida Stem Cell Clinic
Agency concerned about 'significant deviations from current good manufacturing practice requirements'
FDA Approves New Treatment for Acute Lymphoblastic Leukemia
For patients with relapsed or refractory B-cell ALL who have received one or two prior treatments
Studies Used for FDA Approval of Device Changes Often Low Quality
And, efficacy of drugs granted accelerated approval often confirmed only years after approval
FDA Approves Mavyret for Hepatitis C
Combo drug is first approved therapy for hepatitis C to require as few as eight weeks of treatment
FDA Approves New Treatment for Acute Myeloid Leukemia
Vyxeos combines two previously approved drugs -- daunorubicin and cytarabine
FDA Approves Idhifa for Some With Acute Myeloid Leukemia
For adults with relapsed or refractory AML who have an IDH2 genetic mutation
FDA Approves Imbruvica to Treat Chronic Graft Versus Host Disease
Drug sanctioned for patients with cGVHD who do not respond to other forms of therapy
FDA Proposes Lowering Nicotine Levels in Cigarettes
Goal is to combat smoking by making it less addictive
FDA Approves First Neonatal MRI Device
Device designed for neonatal brain and head imaging in intensive care units
FDA Approves Nerlynx to Help Prevent HER2+ Breast CA Return
Drug is a kinase inhibitor that works by blocking several enzymes that promote cell growth
