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4D Molecular Doses First Patient in 4D-310 Trial for Fabry Disease americanpharmaceuticalreview
March 16, 2021
4D Molecular Therapeutics announced the first patient has been dosed in the Phase 1/2 clinical trial of 4D-310 for the treatment of Fabry disease.
EC grants Orphan Drug Designation to FLT190, a Fabry Disease treatment europeanpharmaceuticalreview
March 16, 2020
FLT190 gene therapy has been granted Orphan Drug Designation based on preliminary trial data and the positive opinion of an EMA committee.
FDA approves Amicus' Galafold for Fabry disease biospectrumasia
August 14, 2018
The efficacy of Galafold was demonstrated in a six-month, placebo-controlled clinical trial in 45 adults with Fabry disease.
FDA Approves Galafold (migalastat) for the Treatment of Fabry Disease drugs
August 13, 2018
The U.S. Food and Drug Administration today approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease.
Amicus’ Galafold receives TGA approval for Fabry disease treatment in Australia pharmaceutical-technology
August 17, 2017
Amicus Therapeutics has received the Australian Therapeutic Goods Administration (TGA) approval for Galafold (Migalastat) to treat patients with Fabry disease (alpha-galactosidase A deficiency) in the country.
Amicus kicks off launch of Galafold in the UK www.pharmatimes
March 02, 2017
Amicus Therapeutics has kicked off the commercial launch of its rare disease therapy Galafold in the ...
National Institute for Health and Care Excellence (NICE) Issues Final Positive Recommendation for Ga firstwordpharma
January 05, 2017
Amicus Therapeutics announced that the National Institute for Health and Care Excellence (NICE) Highly Specialised Technologies Evaluation Committee (EC) has issued a positive final evaluation determination (FED) for reimbursed patient access to Galafold™