Latest FDA Approved Drugs and Treatments
Latest FDA Approved Drugs and Treatments
Staying updated with the latest FDA approvals is crucial for healthcare professionals and patients alike.
In this article, we highlight some of the most recent drug and treatment approvals by the U.S. Food and Drug Administration (FDA).
Table of Contents
- Neffy: Nasal Spray for Allergic Reactions
- Encelto: Gene Therapy for Macular Telangiectasia Type 2
- Romvimza: Treatment for Tenosynovial Giant Cell Tumor
- Gomekli: Therapy for Neurofibromatosis Type 1
- Journavx: Non-Opioid Pain Relief
- Datroway: Advanced Breast Cancer Treatment
- Biosimilars: Expanding Treatment Options
- Merilog: Rapid-Acting Insulin Biosimilar
Neffy: Nasal Spray for Allergic Reactions
On March 5, 2025, the FDA expanded the use of ARS Pharmaceuticals' nasal spray, Neffy, to include patients weighing between 15 and 30 kilograms.
Neffy serves as an alternative to traditional epinephrine autoinjectors, such as EpiPen, offering a needle-free option for treating severe allergic reactions, including anaphylaxis.
This expansion is expected to increase prescriptions, particularly during the back-to-school period.
Neffy 1 mg will be available by the end of May in the U.S., priced similarly to the 2 mg version at $199 for two doses.
The company is also working on a lower dose for smaller children.
Encelto: Gene Therapy for Macular Telangiectasia Type 2
On March 7, 2025, the FDA approved Encelto (revakinagene taroretcel-lwey), an allogeneic encapsulated cell-based gene therapy for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel).
MacTel is a rare progressive disease of the macula, leading to degeneration of the photoreceptors, which are specialized light-detecting cells in the back of the eye.
This approval offers a new therapeutic option for individuals affected by this condition.
Romvimza: Treatment for Tenosynovial Giant Cell Tumor
In February 2025, the FDA approved Romvimza (vimseltinib) for the treatment of adults with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection would potentially cause worsening functional limitation or severe morbidity.
Vimseltinib is a kinase inhibitor that targets the colony-stimulating factor 1 receptor (CSF1R), addressing the underlying pathology of TGCT.
The approval was based on the efficacy demonstrated in clinical trials, offering a non-surgical treatment option for patients with this condition.
Gomekli: Therapy for Neurofibromatosis Type 1
Gomekli (mirdametinib) received FDA approval on February 11, 2025, for the treatment of individuals with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas not amenable to complete resection.
Mirdametinib is a kinase inhibitor targeting the MEK1 and MEK2 pathways, which are implicated in the development of these tumors.
This approval provides a therapeutic option for patients with NF1, a condition characterized by the growth of benign tumors along nerves.
Journavx: Non-Opioid Pain Relief
On January 30, 2025, the FDA approved Journavx (tramadol hydrochloride extended-release) for the management of moderate to severe chronic pain.
Journavx is a novel non-opioid alternative that provides extended pain relief while minimizing the risk of addiction and dependency.
This approval marks a significant step in addressing the opioid crisis by offering a safer pain management solution.
Datroway: Advanced Breast Cancer Treatment
Datroway (dazostelimab) was approved by the FDA in February 2025 for the treatment of advanced or metastatic hormone receptor-positive, HER2-negative breast cancer.
This targeted therapy works by inhibiting specific pathways that allow cancer cells to grow and spread.
Clinical trials have shown improved progression-free survival rates among patients using Datroway in combination with endocrine therapy.
Biosimilars: Expanding Treatment Options
Several biosimilars have gained FDA approval in recent months, broadening treatment options for patients requiring biologic therapies.
Biosimilars offer more affordable alternatives to brand-name biologics while maintaining similar efficacy and safety profiles.
Recently approved biosimilars include alternatives for treatments targeting autoimmune diseases, cancer, and diabetes.
Merilog: Rapid-Acting Insulin Biosimilar
Merilog, a newly approved biosimilar to rapid-acting insulin Lispro, was given the green light by the FDA in March 2025.
This insulin therapy is designed to help people with diabetes manage blood sugar levels more effectively after meals.
The approval of Merilog aims to improve access to cost-effective diabetes treatments.
Conclusion
The recent FDA approvals highlight ongoing advancements in medicine, bringing innovative therapies to patients across various medical fields.
From non-opioid pain management to cutting-edge gene therapies, these new treatments offer hope for improved patient outcomes.
Staying informed about these approvals is essential for healthcare professionals and individuals managing chronic conditions.
For the latest FDA updates, visit the FDA Official Website.
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