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.
- Drug:
- Control-IQ+
- Announced Date:
- March 19, 2025
- Indication:
- AID Technology in Type 2 Diabetes
Announcement
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.
AI Summary
Tandem Diabetes Care, Inc. announced that positive results from its pivotal trial of the Control-IQ+ automated insulin delivery (AID) technology for people with type 2 diabetes have been published in The New England Journal of Medicine (NEJM). The study showed that users of Control-IQ+ achieved a significant improvement in blood sugar control, with an average A1C reduction of 0.9% compared to 0.3% in a control group. Participants who began the trial with an A1C of 9% or higher experienced a reduction of 2.3%, highlighting the potential of this technology to help manage high blood sugar.
The trial was conducted on a racially and socio-economically diverse group of adults aged 19 to 87. These promising results support the use of Control-IQ+ for improving glycemic outcomes and potentially reducing the daily therapy burden for people with type 2 diabetes who rely on insulin.
Read Announcement
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
FDA Event Stage Terminology & Abbreviation Guide
- 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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