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FDA Approves New Treatment for Acute Myeloid Leukemia

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Vyxeos combines two previously approved drugs -- daunorubicin and cytarabine

FDA Approves Idhifa for Some With Acute Myeloid Leukemia

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For adults with relapsed or refractory AML who have an IDH2 genetic mutation

FDA Approves Imbruvica to Treat Chronic Graft Versus Host Disease

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Drug sanctioned for patients with cGVHD who do not respond to other forms of therapy
The first magnetic resonance imaging device designed specifically for neonatal brain and head imaging in intensive care units has been approved by the U.S. Food and Drug Administration.

FDA Approves First Neonatal MRI Device

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Device designed for neonatal brain and head imaging in intensive care units
Nerlynx (neratinib) has been approved by the U.S. Food and Drug Administration to help prevent human epidermal growth factor receptor type 2-positive breast cancer from returning.

FDA Approves Nerlynx to Help Prevent HER2+ Breast CA Return

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Drug is a kinase inhibitor that works by blocking several enzymes that promote cell growth
The U.S. Food and Drug Administration has approved Endari (L-glutamine oral powder) to treat patients with sickle cell disease.

FDA Approves Endari for the Treatment of Sickle Cell Disease

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First treatment approved for patients with sickle cell disease in almost 20 years
A cooling cap approved in 2015 for use in breast cancer patients has received expanded approval from the U.S. Food and Drug Administration.

FDA Expands Use of Cooling Cap to Cut Chemo-Related Hair Loss

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Treatment now approved for patients receiving chemotherapy for solid tumors
Keytruda (pembrolizumab) has been approved by the U.S. Food and Drug Administration to treat any cancer that has a certain genetic biomarker

FDA Approves Keytruda for All Cancers With Genetic Biomarker

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First medication sanctioned for any cancer, regardless of origin
The injected drug Actemra (tocilizumab) has been approved by the U.S. Food and Drug Administration to treat adults with giant cell arteritis.

FDA Approves Actemra to Treat Giant Cell Arteritis

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New indication provides the first FDA-approved therapy specific to this type of vasculitis
The U.S. Food and Drug Administration says it has expanded approval for the cystic fibrosis drug Kalydeco (ivacaftor) to include 33 mutations of the disease

FDA OKs Kalydeco for Additional Mutations in Cystic Fibrosis

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Decision based on results of laboratory testing and previous clinical trials