Amicus Therapeutics Announces Positive Long-Term Data from Phase 3 Open-label…
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Amicus Therapeutics
Amicus Therapeutics Receives Positive CHMP Opinion for Pombiliti™ (cipaglucosidase…
CHMP Adopts Positive Opinion Based Upon Complete Review of all Pre-Clinical, Clinical Studies and CMC Data CHMP Recommends Label for Long-Term Enzyme Replacement Therapy in…
Amicus Therapeutics Provides EU Regulatory Update for AT-GAA
PHILADELPHIA, Nov. 07, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on developing and commercializing novel…
U.S. FDA Defers Action on Filing for AT-GAA in Late-onset Pompe Disease
FDA Issues Deferred Action Letter on AT-GAA Regulatory Filing Due to the Inability to Conduct Required Manufacturing Site Inspection Prior to the PDUFA Action Date Company is Now…
Amicus Therapeutics to Present at the Cowen 42nd Annual Health Care Conference
PHILADELPHIA, March 01, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that members of the Amicus senior leadership team will participate in a fireside chat…
European Medicines Agency Validates Amicus Therapeutics Marketing Authorization…
PHILADELPHIA, Dec. 03, 2021 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that the European Medicines Agency (EMA) validated the Marketing Authorization…