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Amicus Therapeutics (FOLD) FDA Events

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FDA Events for Amicus Therapeutics (FOLD)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Amicus Therapeutics (FOLD). Over the past two years, Amicus Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as cipa+mig and Pombiliti. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Amicus Therapeutics' Drugs in FDA Review

cipa+mig - FDA Regulatory Timeline and Events

cipa+mig is a drug developed by Amicus Therapeutics for the following indication: In adults with late-onset Pompe disease (LOPD) in Muscle and Nerve. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Pombiliti - FDA Regulatory Timeline and Events

Pombiliti is a drug developed by Amicus Therapeutics for the following indication: For Pompe disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Amicus Therapeutics FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Amicus Therapeutics (FOLD) has reported FDA regulatory activity for the following drugs: Pombiliti and cipa+mig.

The most recent FDA-related event for Amicus Therapeutics occurred on June 25, 2025, involving Pombiliti. The update was categorized as "Approved," with the company reporting: "Amicus Therapeutics announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat) for the treatment of adult patients with late-onset Pompe disease (LOPD)."

Current therapies from Amicus Therapeutics in review with the FDA target conditions such as:

  • For Pompe disease - Pombiliti
  • In adults with late-onset Pompe disease (LOPD) in Muscle and Nerve. - cipa+mig

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:FOLD) was last updated on 7/10/2025 by MarketBeat.com Staff
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