Q3 2025 Recap: 7 Top FDA Approvals to Know

The third quarter of 2025 brought a diverse slate of United States Food and Drug Administration (FDA) approvals spanning cardiology, dermatology, nephrology, pulmonology, pain management, rare genetic disorders, and immunology. These approvals reflect continued innovation across both common and rare conditions, delivering new treatment options, expanded indications, and improved convenience for patients. Notable highlights include the first disease-modifying therapy for non-cystic fibrosis bronchiectasis, an expanded pediatric indication for dystrophic epidermolysis bullosa, and the first oral Bruton’s tyrosine kinase inhibitor for chronic spontaneous urticaria (CSU). Across all therapeutic areas, these FDA decisions were supported by robust phase 3 clinical data demonstrating meaningful improvements in clinical outcomes, quality of life, and long-term safety.

From cardiometabolic care with finerenone in adults with heart failure with preserved or mildly reduced ejection fraction, to novel non-steroidal topical and sublingual therapies in dermatology and fibromyalgia, Q3 approvals showcase both incremental and transformative advances. Patients with rare diseases also benefited, with first-in-class therapies for complement-mediated kidney disease and genetic skin disorders, while treatment landscapes for chronic hand eczema and CSU gained convenient new treatment options that address previously unmet needs.

Check out this Q3 2025 FDA news month in review for a recap of HCPLive’s coverage of the top FDA approvals and research from the past few months:

Top FDA Approvals in Q3 2025:

1. Finerenone (Kerendia)
Date: July 14, 2025
Indication: Reducing the risk of cardiovascular death, hospitalization, and urgent visits for heart failure in adults with HFmrEF and HFpEF (LVEF ≥40%).
Background: Approval was supported by the phase 3 FINEARTS-HF trial, which demonstrated significant benefits of finerenone in patients with mildly reduced or preserved ejection fraction, expanding its role in cardiorenal protection.

2. Delgocitinib (Anzupgo)
Date: July 23, 2025
Indication: Moderate-to-severe chronic hand eczema in adults with inadequate response to, or for whom topical corticosteroids are not advisable
Background: Approval supported by results from the phase 3 DELTA 1 and DELTA 2 trials, which demonstrated the efficacy and safety of delgocitinib cream as a non-steroidal topical option. This marks the first FDA-approved treatment specifically for chronic hand eczema, addressing a significant unmet need in adults with limited therapeutic alternatives.

3. Pegcetacoplan (Empaveli)
Date: July 28, 2025
Indication: Treatment of C3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients aged 12 years and older, including post-transplant disease recurrence.
Background: Approval supported by 26-week results from the phase 3 VALIANT trial, the largest trial in C3G and IC-MPGN and the only one to include both adolescent and adult patients with native and post-transplant kidneys. Pegcetacoplan represents the first approved therapy for these rare complement-driven kidney diseases, offering a new treatment pathway for patients with limited options.

4. Brensocatib (Brinsupri)
Date: August 12, 2025
Indication: Treatment of non-cystic fibrosis bronchiectasis in adults and adolescents aged 12 years and older
Background: Approval supported by the phase 3 ASPEN trial, which showed significant reductions in pulmonary exacerbation rates over 52 weeks compared with placebo. Nearly half of patients on brensocatib remained exacerbation-free at one year, with additional improvements in lung function observed, particularly at the higher dose. Safety findings were consistent overall, with hyperkeratosis more common in treated patients. This marks the first disease-modifying therapy approved for bronchiectasis.

5. TNX-102 SL (Tonmya)
Date: August 15, 2025
Indication: Treatment of fibromyalgia in adults
Background: The first new fibromyalgia therapy approved in over 15 years, TNX-102 SL is a sublingual cyclobenzaprine formulation and the first in a new class of non-opioid analgesics for this condition. Approval was based on the phase 3 RESILIENT trial, which showed significant reductions in daily pain scores along with improvements in sleep, fatigue, and quality of life. With a tolerable safety profile and rapid onset, TNX-102 SL offers a long-awaited therapeutic option for patients with limited prior treatment choices.

6. Beremagene Geperpavec-svdt (Vyjuvek)
Date: September 15, 2025
Indication: Expanded use for dystrophic epidermolysis bullosa (DEB) patients from birth
Background: The FDA approved a label update for Vyjuvek, extending its use to infants with DEB and permitting at-home caregiver application. The update also allows greater flexibility in wound dressing changes, facilitating integration into daily care routines. Supported by real-world evidence and extension study data, this decision reinforces Vyjuvek’s long-term safety and efficacy while improving convenience and access for patients across all ages and care settings.

7. Remibrutinib (Rhapsido)
Date: September 30, 2025
Indication: Treatment of adults with chronic spontaneous urticaria (CSU) uncontrolled by antihistamines
Background: The FDA approved remibrutinib, a highly selective Bruton’s tyrosine kinase (BTK) inhibitor, offering the first oral alternative to omalizumab for CSU. Supported by phase 3 REMIX-1 and REMIX-2 trials, remibrutinib showed rapid and durable reductions in hives and itching, with nearly half of patients achieving complete relief (UAS7=0) at one year. The therapy was well-tolerated, with a safety profile similar to placebo. This approval provides a convenient new option for patients whose symptoms remain uncontrolled despite antihistamine therapy.