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Insulet (PODD) FDA Events

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FDA Events for Insulet (PODD)

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

Omnipod 5 - FDA Regulatory Timeline and Events

Omnipod 5 is a drug developed by Insulet for the following indication: Automated Insulin Delivery System for with type 1 diabetes (T1D). 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.

Insulet FDA Events - Frequently Asked Questions

As of now, Insulet (PODD) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Insulet (PODD) has reported FDA regulatory activity for Omnipod 5.

The most recent FDA-related event for Insulet occurred on August 26, 2024, involving Omnipod 5. The update was categorized as "Provided Update," with the company reporting: "Insulet Corporation announced its groundbreaking Omnipod 5 Automated Insulin Delivery System (Omnipod 5) is now indicated for use by people with type 2 diabetes (ages 18 years and older) in the U.S., making it the first and only AID system FDA-cleared for both type 1 and type 2 diabetes management."

Currently, Insulet has one therapy (Omnipod 5) targeting the following condition: Automated Insulin Delivery System for with type 1 diabetes (T1D).

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:PODD) was last updated on 7/10/2025 by MarketBeat.com Staff
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