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SkyePharma PLC (LSE: SKP) today announces that the New Drug Application (NDA) for Flutiform? (fluticasone propionate/formoterol fumarate) in the U.S. is being transferred to SkyePharma.
As previously announced, following receipt of the Complete Response Letter in January, discussions are being sought with the U.S. Food and Drug Administrat
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AVI BioPharma, Inc. (NASDAQ:AVII), a developer of RNA-based drugs, today announced that it received an orphan drug designation from the Committee for Orphan Medical Products of the European Medicines Agency (EMEA) for AVI-5038, a drug candidate being developed by AVI for the treatment of Duchenne Muscular Dystrophy (DMD). DMD is a genetic muscle-wa
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Solvay Pharmaceuticals, Inc. announced today that Phase IIIb data published in the January issue of Clinical Therapeutics confirm that CREON® (pancrelipase) Delayed-Release Capsules significantly improves a key measure of fat absorption in children aged 7-11 years who have exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), EPI is
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Talecris Biotherapeutics, Inc. (Nasdaq: TLCR) announced today that it was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the development of an aerosol formulation of Alpha1-Proteinase Inhibitor (Human, A1PI) to treat congenital alpha1-antitrypsin (AAT) deficiency. AAT deficiency is a chronic, hereditary condition
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