7 Key FDA Decisions to Watch in the Second Half of 2025

As the first half of 2025 delivered a remarkable series of approvals across diabetes, HIV prevention, rare diseases, and more, the momentum of innovation shows no signs of slowing. Yet this progress unfolds against a backdrop of uncertainty for many in public health: persistent disparities, strained care systems, and questions around access remain pressing challenges. In this complex landscape, the second half of 2025 is poised to bring pivotal FDA decisions that could shape care for millions.

From potential first-in-class treatments for rare kidney and respiratory diseases, to new options for fibromyalgia, menopause symptoms, and heart failure, these upcoming verdicts span diverse therapeutic areas with significant unmet needs. Whether offering non-opioid solutions for chronic pain, disease-modifying therapies for autoimmune and renal conditions, or expanded tools for cardiovascular care, each decision carries the potential to redefine standards and improve outcomes.

Listed chronologically, these seven FDA decisions were selected for their potential to impact public health and the historic nature of the therapies under review. Here’s what to watch as the second half of 2025 unfolds—and why these approvals could set the tone for the future of patient care.

In this article, we highlight, in chronological order according to PDUFA date, 7 FDA decisions to watch in H2 2025.

FDA Decisions to Watch in H2 2025

1. Elinzanetant
PDUFA Date: July 26, 2025
Indication: Vasomotor Symptoms of Menopause
Company: Bayer
Summary:
Bayer’s NDA for elinzanetant, supported by OASIS 1-3 phase 3 trials showing significant reductions in hot flash frequency and severity, has been accepted by the FDA with a PDUFA date expected soon. Elinzanetant, the first dual NK-1/3 receptor antagonist in late-stage development, offers a non-hormonal option for moderate-to-severe vasomotor symptoms. Approval could revolutionize menopause care for millions seeking alternatives to hormonal therapies.

2. Pegcetacoplan
PDUFA Date: July 28, 2025
Indication: C3 Glomerulopathy and IC-MPGN
Company: Apellis Pharmaceuticals
Summary:
On July 28, 2025, the FDA is expected to decide on pegcetacoplan (Empaveli) for treating C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis. The phase 3 VALIANT trial showed a 68% reduction in proteinuria, stabilization of kidney function, and substantial clearance of C3c staining, with consistent benefits across patient groups. Approval would mark the first disease-modifying therapy for these rare, progressive kidney diseases at high risk of renal failure.

3. Brensocatib
PDUFA Date: August 12, 2025
Indication: Non-Cystic Fibrosis Bronchiectasis
Company: Insmed
Summary:
On August 12, 2025, the FDA will decide on brensocatib for non-cystic fibrosis bronchiectasis, based on the phase 3 ASPEN trial meeting its primary endpoint of reducing pulmonary exacerbations over 52 weeks in both dose groups. Brensocatib, a DPP1 inhibitor, would be the first approved treatment for this chronic, progressive respiratory disease, potentially transforming care for thousands. The therapy also significantly prolonged time to first exacerbation and slowed lung function decline.

4. TNX-102 SL
PDUFA Date: August 15, 2025
Indication: Fibromyalgia
Company: Tonix Pharmaceuticals
Summary:
Tonix Pharmaceuticals’ TNX-102 SL (cyclobenzaprine HCl sublingual tablets) NDA acceptance brings hope for fibromyalgia patients, with the RELIEF and RESILIENT phase 3 trials showing significant daily pain reductions (P = .010 and P = .00005, respectively) compared to placebo. If approved, TNX-102 SL would be the first new fibromyalgia drug in over 15 years, addressing a major unmet need with a non-opioid treatment targeting non-restorative sleep. The FDA granted Fast Track designation, and a PDUFA date is expected soon.

5. Obinutuzumab
PDUFA Date: October 31, 2025
Indication: Lupus Nephritis
Company: Roche
Summary:
By October 2025, the FDA is expected to decide on obinutuzumab (Gazyva) for lupus nephritis, supported by phase 3 REGENCY data showing 46.4% of patients achieved complete renal response versus 33.1% on standard therapy alone (P=0.0232). Obinutuzumab targets CD20-positive B cells to control disease activity, preserve kidney function, and delay progression to end-stage disease. Approval could expand treatment options for this serious autoimmune condition affecting young adults.

6. Finerenone
PDUFA date: Q3
Indication: Heart Failure with LVEF ≥40% (HFmrEF/HFpEF)
Company: Bayer
Summary:
On March 17, 2025, Bayer announced the FDA accepted its sNDA for finerenone (KERENDIA) to treat adults with heart failure with mildly reduced or preserved ejection fraction (LVEF ≥40%), granting Priority Review designation. The submission is supported by the phase 3 FINEARTS-HF trial, which showed a significant 16% reduction in the composite of cardiovascular death and total heart failure events compared with placebo (P = .007), with comparable serious adverse event rates between groups. Approval could bring the first non-steroidal mineralocorticoid receptor antagonist therapy to a large population of HFmrEF/HFpEF patients, addressing a major unmet need with high mortality and hospitalization rates.

7. Aficamten
PDUFA Date: December 26, 2025
Indication: Obstructive Hypertrophic Cardiomyopathy
Company: Cytokinetics
Summary:
On December 26, 2025, the FDA is set to decide on aficamten for obstructive hypertrophic cardiomyopathy, supported by the SEQUOIA-HCM phase 3 trial showing a 1.74 mL/kg/min improvement in peak oxygen uptake (P=0.000002) and significant gains across 10 secondary endpoints. Aficamten, a next-in-class cardiac myosin inhibitor, could expand treatment options for this leading cause of heart failure and sudden death in young adults. The therapy demonstrated consistent efficacy and a favorable safety profile.