Specialty Pharma Journal Specialty, Precision & Technology
CRANBURY, N.J., Sept. 20, 2018 (GLOBE NEWSWIRE) — Amicus Therapeutics (Nasdaq: FOLD) today announced the signing of a definitive agreement in which Amicus Therapeuticswill receive worldwide development and commercial rights for ten gene therapy programs developed at The Center for Gene Therapy at The Research Institute at Nationwide Children’s Hospital and The Ohio State University. The ten programs are licensed …
Tag Archives: Amicus Therapeutics
September, 2018
August, 2018
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13 August
FDA Approves Amicus’ Galafold for Treatment of Adults with Fabry Disease
CRANBURY, N.J., Aug. 10, 2018 (GLOBE NEWSWIRE) — Amicus Therapeutics (Nasdaq: FOLD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Galafold™ (migalastat) 123 mg capsules. Galafold is an oral, precision medicine for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha …
July, 2016
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8 July
Amicus Acquires MiaMed Gaining Rare Disease Preclinical Program
CRANBURY, N.J., July 06, 2016 (GLOBE NEWSWIRE) — Amicus Therapeutics, Inc. (Nasdaq:FOLD), a biotechnology company at the forefront of rare and orphan diseases, has expanded its biologics pipeline with a new preclinical program for cyclin-dependent kinase-like 5 (CDKL5) deficiency, a rare and devastating genetic neurological disease for which there is …
March, 2015
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20 March
Amicus to Seek Accelerated US and European Approval of its Investigational Fabry Disease Drug
Amicus Therapeutics announced its plans to file for accelerated approval of its investigational drug for a rare, inherited disease, following meetings with regulators in the US and Europe. The company said that it has recently met with regulatory authorities in Europe and the US to discuss the approval pathways for …