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Monmouth Junction, NJ—October 20, 2015—Tris Pharma, Inc. (Tris) announced that the US Food and Drug Administration (FDA) has approved Dyanavel XR (amphetamine), extended­release oral suspension, CII, for the treatment of attention-deficit/ hyperactivity disorder (ADHD) in children aged ≥6 years. With this approval, Dyanavel XR becomes the only once­daily, extended release amphetamine­based oral liquid approved for the treatment of ADHD in children.
The US Food and Drug Administration (FDA) today granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.
Paris, France—September 29th, 2015—Sanofi announced today that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for lixisenatide, an investigational once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes mellitus (T2DM).
On September 30, 2015, the US Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo Injection, Bristol-Myers Squibb Company) in combination with ipilimumab for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma.
The US Food and Drug Administration (FDA) granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non–small-cell lung cancer (NSCLC) whose disease has progressed after other treatments, and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non–small-cell lung tumors.
On October 5, the US Food and Drug Administration (FDA) approved Aristada (aripiprazole lauroxil) extended release injection to treat adults with schizophrenia. Aristada is administered by a healthcare professional every 4 to 6 weeks using an injection in the arm or buttocks.
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