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
NU-GEN, Obagi®, and MagIQ™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
NU-GEN FDA Regulatory Events
NU-GEN is a drug developed by Waldencast for the following indication: Cellular Renewal Serum.
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:
- NU-GEN
- Announced Date:
- March 24, 2026
- Indication:
- Cellular Renewal Serum
Announcement
Obagi Medical and part of Waldencast plc announce the latest innovation in advanced skin science and longevity with the launch of its newest breakthrough: Obagi NU-GEN™ Cellular Renewal Serum.
AI Summary
Obagi Medical, part of Waldencast plc, announced NU-GEN™ Cellular Renewal Serum, a new skin-care product that targets cellular aging. The serum combines NAD+ with its precursors NMN and niacinamide to help replenish an essential coenzyme inside skin cells. Obagi’s chief medical director, Dr. Suzan Obagi, says this multi‑ingredient approach lets the brand address several signs of aging at once and deliver measurable, clinically validated improvements in skin health and appearance.
The company cites 2025 clinical testing: a 12-week aging study, a 12-week blemish-prone study, and a 48-hour hydration test, with data on file at Obagi Cosmeceuticals; individual results may vary. A media contact is provided with the announcement. NU-GEN is positioned as a science-driven topical treatment that uses NAD+ biology to support skin repair and longevity for consumers seeking evidence-based anti-aging options.
Read Announcement
Obagi® FDA Regulatory Timeline and Events
Obagi® is a drug developed by Waldencast for the following indication: Injectable Hyaluronic Acid Gel.
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:
- Obagi®
- Announced Date:
- February 17, 2026
- Indication:
- Injectable Hyaluronic Acid Gel
Announcement
Obagi Medical and aesthetic solutions and part of Waldencast plc announced Aesthetic Record as a key partner for the Aesthetics Leadership with Obagi's Hyaluronic Acid (ALOHA) Program.
AI Summary
Obagi Medical and Aesthetic Solutions, part of Waldencast plc, named Aesthetic Record a key partner for the Aesthetics Leadership with Obagi’s Hyaluronic Acid (ALOHA) Program. Aesthetic Record will present initial findings at the upcoming Aesthetic Next conference, showing how the new protocols and product work inside its practice management and clinical ecosystem. The company plans to share results at other industry conferences to show the real-world impact of introducing this injectable across thousands of aesthetic practices that use Aesthetic Record.
The ALOHA offering includes Obagi® saypha® MagIQ™, developed by Croma‑Pharma, which uses MACRO Core Technology to form a stable three-dimensional hyaluronic acid matrix. That design aims for natural-looking results with high usable HA on injection, even gel distribution, and predictable injection force and swelling. The partnership is meant to speed adoption and build evidence for clinicians interested in the new protocols. More info: https://obagi-professional.com
Read Announcement- Drug:
- Obagi®
- Announced Date:
- January 27, 2026
- Indication:
- Injectable Hyaluronic Acid Gel
Announcement
Obagi Medical and part of Waldencast plc announced that it has partnered with Alpha Aesthetic Partners for the Aesthetics Leadership with Obagi‘s Hyaluronic Acid (ALOHA) Program.
AI Summary
Obagi Medical, part of Waldencast plc, has partnered with Alpha Aesthetics Partners to launch the Aesthetics Leadership with Obagi’s Hyaluronic Acid (ALOHA) Program. Alpha was chosen as a launch partner for its focus on innovation, education, and scalable, high-quality care. Through this collaboration, Alpha will run a structured, multi-site evaluation of Obagi’s saypha MagIQ across its network, using standardized protocols and training to support providers and patients.
The ALOHA Program will collect real-world data on clinical performance and patient experience to show how Obagi’s hyaluronic acid filler performs in diverse practice settings. Initial findings will be shared at the Alpha Summit and at industry conferences. Obagi and Alpha say the work aims to deepen patient relationships, improve outcomes, and build consistent, evidence-driven approaches to combining skincare and injectables. Alpha’s network spans 31 locations in 12 states.
Read Announcement- Drug:
- Obagi®
- Announced Date:
- January 21, 2026
- Indication:
- Injectable Hyaluronic Acid Gel
Announcement
Waldencast plc announced the launch of the ALOHA (Aesthetic Leadership with Obagi Hyaluronic Acid) Program.
AI Summary
Waldencast’s Obagi Medical announced the ALOHA (Aesthetic Leadership with Obagi Hyaluronic Acid) Program, a structured clinical collaboration designed to speed aesthetic innovation using practice-led insights. The program supports the rollout of Obagi® saypha® MagIQ™ by collecting real-world data from diverse clinical settings. Participating practices will use the product in routine treatments and submit standardized feedback from injectors and practice owners, capturing practical experience that goes beyond controlled trials.
ALOHA aims to shape post-launch education, scientific content, and broader adoption by turning real-world practice data into actionable insights. The company expects the effort to become the largest real-world evaluation of a newly launched HA injectable. The program emphasizes inclusivity under Obagi’s Aesthetics for All™ ethos and invites practices to sign up or contact their Obagi representative for more information.
Read Announcement- Drug:
- Obagi®
- Announced Date:
- November 16, 2025
- Indication:
- Injectable Hyaluronic Acid Gel
Announcement
Obagi Medical, a leading innovator in physician-dispensed skincare and aesthetic solutions and part of Waldencast plc announced new data shared at the recent American Society for Dermatologic Surgery (ASDS) Annual Meeting, which took place November 13–16, 2025, in Chicago, Illinois.
AI Summary
Obagi Medical, part of Waldencast plc, shared new clinical data at the American Society for Dermatologic Surgery (ASDS) meeting in Chicago (Nov. 13–16, 2025). A pivotal, randomized multicenter trial comparing two hyaluronic acid fillers for midface augmentation and nasolabial fold improvement showed that Obagi® saypha® ChIQ™ was non‑inferior to Juvéderm Voluma® XC. The study reported high patient satisfaction and a favorable safety profile across diverse skin types. Investigator Dr. Sue Ellen Cox highlighted that the saypha ChIQ data was selected as one of the top 10 abstracts and chosen for an oral presentation.
Obagi also presented interim three‑month results for Nu‑Cil® BioStim™ Scalp Serum, showing early improvements in scalp health and hair appearance, and introduced a new scientific framework for comparing hyaluronic acid crosslinking technologies. Company leaders emphasized these findings as evidence of Obagi’s continued focus on clinically driven innovation in skincare and injectables.
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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
