Waldencast's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Waldencast (WALD).
Over the past two years, Waldencast has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
MagIQ™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
MagIQ™ FDA Regulatory Events
MagIQ™ is a drug developed by Waldencast for the following indication: .
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:
- MagIQ™
- Announced Date:
- September 10, 2025
- Indication:
Announcement
Waldencast plc announced that the U.S. Food and Drug Administration ("FDA") has approved Obagi® saypha® MagIQ™ injectable hyaluronic acid ("HA") gel, the first product in the Obagi® saypha® collection under the Obagi Medical brand.
AI Summary
Waldencast plc announced FDA approval of Obagi® saypha® MagIQ™ injectable hyaluronic acid gel, the first product in the Obagi® saypha® collection under the Obagi Medical brand. This approval marks the company’s entry into the U.S. dermal filler market and supports its goal to double Obagi Medical’s addressable market. Michel Brousset, Co-Founder and CEO of Waldencast, said this milestone advances their strategy to become a leading dermatological megabrand bridging skincare and medical aesthetics.
Obagi® saypha® MagIQ™ was developed by Croma-Pharma using proprietary MACRO Core Technology that forms a stable three-dimensional hyaluronic acid matrix for natural-looking results. It offers high hyaluronic acid content per injection and consistent gel distribution.
Waldencast plans to launch the gel in 2026 alongside skincare innovations, leveraging Obagi Medical’s network of practices. This launch will expand accounts, create synergies with its skincare business, and deliver new options for precise, natural-looking results.
Read Announcement
Waldencast FDA Events - Frequently Asked Questions
As of now, Waldencast (WALD) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Waldencast (WALD) has reported FDA regulatory activity for MagIQ™.
The most recent FDA-related event for Waldencast occurred on September 10, 2025, involving MagIQ™. The update was categorized as "FDA approved," with the company reporting: "Waldencast plc announced that the U.S. Food and Drug Administration ("FDA") has approved Obagi® saypha® MagIQ™ injectable hyaluronic acid ("HA") gel, the first product in the Obagi® saypha® collection under the Obagi Medical brand."
Currently, Waldencast does not have any FDA drugs targeting specific conditions or diseases.
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:WALD) was last updated on 9/11/2025 by MarketBeat.com Staff
