Mattel's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Mattel (MAT).
Over the past two years, Mattel has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Barbie. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Barbie FDA Regulatory Events
Barbie is a drug developed by Mattel for the following indication: 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.
- Drug:
- Barbie
- Announced Date:
- July 8, 2025
- Indication:
- type 1 diabetes (T1D)
Announcement
Mattel, Inc announced that Barbie® is debuting the first Barbie doll with type 1 diabetes (T1D).
AI Summary
Mattel, Inc. announced that Barbie® is debuting the first-ever Barbie doll with type 1 diabetes (T1D). Created in partnership with Breakthrough T1D, the doll is part of the global Fashionistas lineup and is designed to represent children living with T1D. The doll features realistic details such as a continuous glucose monitor on her arm, held in place by heart-shaped, Barbie pink medical tape, and an insulin pump attached to her waist. Her stylish blue polka dot outfit and matching accessories are nods to diabetes awareness, helping to foster inclusion and empathy through imaginative play.
This pioneering doll allows more children to see themselves reflected in Barbie, empowering those with T1D by showing that life with the condition can be vibrant and full of possibilities. Barbie’s debut T1D doll highlights the brand’s ongoing commitment to representation and inclusivity.
Read Announcement
Mattel FDA Events - Frequently Asked Questions
As of now, Mattel (MAT) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Mattel (MAT) has reported FDA regulatory activity for Barbie.
The most recent FDA-related event for Mattel occurred on July 8, 2025, involving Barbie. The update was categorized as "Provided Update," with the company reporting: "Mattel, Inc announced that Barbie® is debuting the first Barbie doll with type 1 diabetes (T1D)."
Currently, Mattel has one therapy (Barbie) targeting the following condition: type 1 diabetes (T1D).
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:MAT) was last updated on 7/31/2025 by MarketBeat.com Staff
