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Tandem Diabetes Care (TNDM) FDA Events

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FDA Events for Tandem Diabetes Care (TNDM)

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

Control-IQ+ - FDA Regulatory Timeline and Events

Control-IQ+ is a drug developed by Tandem Diabetes Care for the following indication: AID Technology in Type 2 Diabetes. 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.

Tandem Diabetes Care FDA Events - Frequently Asked Questions

As of now, Tandem Diabetes Care (TNDM) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Tandem Diabetes Care (TNDM) has reported FDA regulatory activity for Control-IQ+.

The most recent FDA-related event for Tandem Diabetes Care occurred on March 19, 2025, involving Control-IQ+. The update was categorized as "Published Results," with the company reporting: "Tandem Diabetes Care, Inc announced publication by The New England Journal of Medicine (NEJM) of positive results from the company's pivotal trial of Control-IQ+ automated insulin delivery (AID) technology in people with type 2 diabetes."

Currently, Tandem Diabetes Care has one therapy (Control-IQ+) targeting the following condition: AID Technology in Type 2 Diabetes.

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