FDA Events for Tarsus Pharmaceuticals (TARS)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Tarsus Pharmaceuticals (TARS).
Over the past two years, Tarsus Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
XDEMVY. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
XDEMVY - FDA Regulatory Timeline and Events
XDEMVY is a drug developed by Tarsus Pharmaceuticals for the following indication: For the treatment of Demodex blepharitis.
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:
- XDEMVY
- Announced Date:
- February 25, 2025
- Indication:
- For the treatment of Demodex blepharitis
Announcement
Tarsus Pharmaceuticals, Inc. announced recent business achievements.
AI Summary
Tarsus Pharmaceuticals, Inc. has made impressive strides in its business achievements during the first full year of XDEMVY’s launch. The company reported fourth quarter net product sales of $66.4 million and full‐year net sales of $180.1 million, highlighting one of the most successful eye care launches to date. XDEMVY demonstrated clear benefits by improving both disease signs and patient symptoms for those suffering from Demodex blepharitis and Meibomian Gland Disease. This success was supported by expanded outreach, with prescriptions increasing significantly as more than 15,000 eye care professionals began to utilize the product. Tarsus further strengthened its market presence by launching a direct-to-consumer campaign across streaming and network TV platforms, which has received positive initial feedback. The company’s strong performance positions it well as it continues to pursue additional innovative treatments in eye care.
Read Announcement
Tarsus Pharmaceuticals FDA Events - Frequently Asked Questions
As of now, Tarsus Pharmaceuticals (TARS) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Tarsus Pharmaceuticals (TARS) has reported FDA regulatory activity for XDEMVY.
The most recent FDA-related event for Tarsus Pharmaceuticals occurred on February 25, 2025, involving XDEMVY. The update was categorized as "Provided Update," with the company reporting: "Tarsus Pharmaceuticals, Inc. announced recent business achievements."
Currently, Tarsus Pharmaceuticals has one therapy (XDEMVY) targeting the following condition: For the treatment of Demodex blepharitis.
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:TARS) was last updated on 7/13/2025 by MarketBeat.com Staff
