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Shire Receives FDA Fast Track Designation for Recombinant ADAMTS13 for Treatment of Hereditary Throm americanpharmaceuticalreview
March 23, 2017
Shire announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for recombinant ADAMTS13 (SHP655 - historically known as BAX930) for treatment of acute episodes...
FDA Approves Xadago® for Parkinson’s Disease Patients americanpharmaceuticalreview
March 23, 2017
Newron Pharmaceuticals S.p.A. announced that the Food and Drug Administration (FDA) has approved the use of Xadago® (safinamide) for the treatment of Parkinson’s disease as add-on therapy to levodopa/carbidopa.
FDA permits Akashi Therapeutics to resume clinical trials of experimental DMD drug HT-100 firstwordpharma
March 23, 2017
Akashi Therapeutics on Wednesday announced that it received approval from the FDA to restart clinical studies of the experimental Duchenne muscular dystrophy (DMD) treatment HT-100.
FDA OK’s first novel treatment for Parkinson’s in ten years pharmatimes
March 23, 2017
The US Food and Drug Administration has approved the first novel treatment option in more than a decade for patients...
US FDA approves Xadago to treat patients with Parkinson’s disease pharmaceutical-technology
March 23, 2017
The US Food and Drug Administration (FDA) has approved Newron Pharmaceuticals’ Xadago (safinamide) tablets to ...
Mylan receives tentative approval for "TLE400" under PEPFAR cphi-online
March 23, 2017
TLE400 is a fixed-combination containing Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 400 mg/300 mg/300 mg.
FDA approves drug to treat Parkinson’s disease FDA
March 23, 2017
The U.S. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes.
FDA clears Newron, Zambon, US WorldMeds' Xadago for Parkinson's disease firstwordpharma
March 22, 2017
The FDA approved Newron Pharmaceuticals, Zambon and US WorldMeds' Xadago (safinamide) as an add-on therapy to levodopa/carbidopa for patients with Parkinson's disease, the companies announced Tuesday.
FDA Approves Xadago drugs.com
March 22, 2017
FDA Approves Xadago (safinamide) as an Add-On Treatment for Patients with Parkinson’s Disease
Divis Labs gets US FDA import alert financialexpress
March 22, 2017
The company has announced that it is working with third party consultants to address concerns of USFDA

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