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SpringWorks Therapeutics (SWTX) FDA Approvals

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As of 07/1/2025

SpringWorks Therapeutics' Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by SpringWorks Therapeutics (SWTX). Over the past two years, SpringWorks Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Mirdametinib and Nirogacestat. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

Mirdametinib FDA Regulatory Timeline and Events

Mirdametinib is a drug developed by SpringWorks Therapeutics for the following indication: Adult and pediatric patients with NF1-associated plexiform neurofibromas (NF1-PN). This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Nirogacestat FDA Regulatory Timeline and Events

Nirogacestat is a drug developed by SpringWorks Therapeutics for the following indication: Ovarian Granulosa Cell Tumors. 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.

SpringWorks Therapeutics FDA Events - Frequently Asked Questions

Yes, SpringWorks Therapeutics (SWTX) has received FDA approval for Mirdametinib. This page tracks recent and historical FDA regulatory events related to SpringWorks Therapeutics' drug portfolio.

In the past two years, SpringWorks Therapeutics (SWTX) has reported FDA regulatory activity for the following drugs: Mirdametinib and Nirogacestat.

The most recent FDA-related event for SpringWorks Therapeutics occurred on July 18, 2025, involving Mirdametinib. The update was categorized as "Marketing authorization," with the company reporting: "SpringWorks Therapeutics, Inc announced that the European Commission (EC) granted conditional marketing authorization for EZMEKLY® (mirdametinib) for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in pediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years and above."

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

  • Adult and pediatric patients with NF1-associated plexiform neurofibromas (NF1-PN) - Mirdametinib
  • Ovarian Granulosa Cell Tumors - Nirogacestat

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:SWTX) was last updated on 8/2/2025 by MarketBeat.com Staff
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