The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Presented below is a comprehensive list of drugs and devices, along with the anticipated decision date.
Upcoming FDA Decisions in 2nd Quarter of 2025
| PDUFA | Drug/Therapy | Company | Description |
|---|---|---|---|
| April 2, 2025 | Reproxalap | Aldeyra Therapeutics | A first-in-class small-molecule modulator of reactive aldehyde species (RASP), is under review for the treatment of the signs and symptoms of dry eye disease. |
| April 3, 2025 | Uplizna (inebilizumab-cdon) | Amgen | For the treatment of adults with generalized myasthenia gravis (gMG). |
| April 18, 2025 | Dupilumab | Sanofi & Regeneron | For the treatment of adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. |
| April 21, 2025 | Nivolumab plus ipilimumab | Bristol Myers Squibb | Nivolumab (Opdivo) plus ipilimumab (Yervoy) as a first line treatment for patients with unresectable hepatocellular carcinoma (HCC). |
| April 26, 2025 | Pixclara (18F-floretyrosine or 18F-FET) | Telix Pharmaceuticals | A PET agent for the characterisation of progressive or recurrent glioma from treatment related changes in both adult and pediatric patients. |
| April 29, 2025 | Elamipretide | Stealth BioTherapeutics | A first-in-class mitochondria-targeted therapeutic, and the first FDA-approved therapy for Barth syndrome. |
| April 29, 2025 | Prademagene zamikeracel (pz-cel) | Abeona Therapeutics | The treatment is an investigational gene therapy which has been developed for individuals with recessive dystrophic epidermolysis bullosa (RDEB). |
| April 30, 2025 | Dihydroergotamine Nasal Powder | Satsuma Pharmaceuticals | For the acute treatment of migraine with or without aura. |
| May 7, 2025 | Nucala (mepolizumab) | GSK | A new indication for the use of Nucala (mepolizumab) in chronic obstructive pulmonary disease or COPD. |
| May 22, 2025 | Zoryve (roflumilast) foam 0.3% | Arcutis Biotherapeutics | For the treatment of both scalp and body psoriasis. |
| May 26, 2025 | Welireg (belzutifan) | Merck | An oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult and pediatric patients (12 years and older) with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma (PPGL). |
| May 28, 2025 | ET-400 | Eton Pharmaceuticals | A proprietary, room temperature stable, oral solution formulation of the approved glucocorticoid hydrocortisone in development for use in children. |
| May 28, 2025 | mRNA-1283 | Moderna | It is a next-generation COVID-19 vaccine. |
| June 10, 2025 | Clesrovimab (MK-1654) | Merck | An investigational prophylactic long-acting monoclonal antibody (mAb) for infants to protect them from respiratory syncytial virus (RSV) disease during their first RSV season. |
| June 13, 2025 | UGN-102 (mitomycin) | UroGen Pharma | For the treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer |
| June 17, 2025 | Sebetralstat | KalVista Pharmaceuticals | A novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 years and older. |
| June 19, 2025 | Lenacapavir | Gilead Sciences | A twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP). |
| June 20, 2025 | Dupixent | Sanofi | For the treatment of adults with bullous pemphigoid (BP), a chronic and severe skin disease associated with type 2 inflammation. |
| June 23, 2025 | Taletrectinib | Nuvation Bio | For the treatment of advanced ROS1-positive Non-Small Cell Lung Cancer. |
| June 23, 2025 | Keytruda (pembrolizumab) | Merck | An anti-PD-1 therapy for the treatment of patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment, then continued as adjuvant treatment in combination with standard of care radiotherapy with or without cisplatin and then as a single agent. |
| June 28, 2025 | Oxylanthanum carbonate (OLC) | Unicycive Therapeutics | For the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis. |
| June 30, 2025 | CUTX-101 (Copper Histidinate) | Cyprium Therapeutics | A therapy for Menkes disease, a rare and life-threatening genetic disorder that affects copper absorption and metabolism. |
| June 30, 2025 | NRX-101 | NRx Pharmaceuticals | This investigational drug is a fixed-dose combination of d-cycloserine and lurasidone for the treatment of bipolar depression. |
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