FDA Events for Biomerica (BMRA)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Biomerica (BMRA).
Over the past two years, Biomerica has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Fortel®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Fortel® Prostate - FDA Regulatory Timeline and Events
Fortel® Prostate is a drug developed by Biomerica for the following indication: Device Study.
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:
- Fortel® Prostate
- Announced Date:
- January 16, 2025
- Indication:
- Device Study
Announcement
Biomerica, Inc announce that its Fortel® Prostate Specific Antigen (PSA) Screening Test has received approval from the United Arab Emirates Ministry of Health and Prevention (MOHAP).
AI Summary
Biomerica, Inc. announced that its Fortel® Prostate Specific Antigen (PSA) Screening Test has received approval from the United Arab Emirates Ministry of Health and Prevention (MOHAP). The test offers rapid results in just 10 minutes using a simple finger-prick blood sample, making it easier to detect elevated PSA levels that can signal prostate cancer or other prostate-related conditions. This innovative approach helps in early detection and better patient care, which is crucial for managing the disease.
This milestone approval supports Biomerica’s strategic expansion in the Middle East, a region where prostate cancer is gaining recognition as a serious public health concern. The Fortel® PSA test has shown excellent performance in evaluations, demonstrating high sensitivity, specificity, and accuracy. By increasing access to quick and reliable diagnostic tools, Biomerica aims to improve early cancer detection and overall health outcomes in the region.
Read Announcement- Drug:
- Fortel® Prostate
- Announced Date:
- September 4, 2024
- Indication:
- Device Study
Announcement
Biomerica, Inc. announce that the Saudi Food and Drug Authority (SFDA) has approved the Company's Fortel® Prostate (PSA) Screening Test to be sold and used in the country.
AI Summary
Biomerica, Inc. has received approval from the Saudi Food and Drug Authority (SFDA) to sell and use its Fortel® Prostate (PSA) Screening Test in Saudi Arabia. This at-home test uses a simple finger-prick blood sample to measure elevated PSA levels, an important early indicator of prostate disease, including cancer. The test delivers highly accurate results in just 10 minutes, making it a convenient tool for early prostate cancer detection. This approval marks a significant milestone in Biomerica’s strategic expansion into the Middle East, a region where prostate cancer is becoming a growing public health concern. With the first order already shipped, Biomerica is set to help improve early diagnosis and treatment options for men, empowering them to take charge of their health from the comfort of their own homes.
Read Announcement
Biomerica FDA Events - Frequently Asked Questions
As of now, Biomerica (BMRA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Biomerica (BMRA) has reported FDA regulatory activity for Fortel® Prostate.
The most recent FDA-related event for Biomerica occurred on January 16, 2025, involving Fortel® Prostate. The update was categorized as "Approved," with the company reporting: "Biomerica, Inc announce that its Fortel® Prostate Specific Antigen (PSA) Screening Test has received approval from the United Arab Emirates Ministry of Health and Prevention (MOHAP)."
Currently, Biomerica has one therapy (Fortel® Prostate) targeting the following condition: Device Study.
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:BMRA) was last updated on 7/12/2025 by MarketBeat.com Staff
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