Free Trial

Phathom Pharmaceuticals (PHAT) FDA Events

Phathom Pharmaceuticals logo
$9.50 +0.13 (+1.43%)
As of 12:44 PM Eastern
This is a fair market value price provided by Polygon.io. Learn more.
FDA Events for Phathom Pharmaceuticals (PHAT)

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

vonoprazan - FDA Regulatory Timeline and Events

vonoprazan is a drug developed by Phathom Pharmaceuticals for the following indication: For the Treatment of Heartburn Associated with Non-Erosive GERD. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Phathom Pharmaceuticals FDA Events - Frequently Asked Questions

Yes, Phathom Pharmaceuticals (PHAT) has received FDA approval for vonoprazan. This page tracks recent and historical FDA regulatory events related to Phathom Pharmaceuticals' drug portfolio.

In the past two years, Phathom Pharmaceuticals (PHAT) has reported FDA regulatory activity for vonoprazan.

The most recent FDA-related event for Phathom Pharmaceuticals occurred on June 16, 2025, involving vonoprazan. The update was categorized as "FDA approved," with the company reporting: "Phathom Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has updated the Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") to accurately reflect the full 10-year period of non-patent New Chemical Entity (NCE) exclusivity for VOQUEZNA® (vonoprazan) 10 mg and 20 mg tablets."

Currently, Phathom Pharmaceuticals has one therapy (vonoprazan) targeting the following condition: For the Treatment of Heartburn Associated with Non-Erosive GERD.

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:PHAT) was last updated on 7/10/2025 by MarketBeat.com Staff
From Our Partners