Clinical Trial News: Year-End 2025 Recap & January 2026 Kickoff
FDA Drug Approvals
Nereus (tradipitant): Approved 30-Dec-2025 for the prevention of vomiting associated with motion sickness in adults. Vanda Pharmaceuticals.
FDA Link Yartemlea (narsoplimab-wuug): Approved 24-Dec-2025 as the first treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Omeros Corporation.
FDA Link Aqvesme (mitapivat): Approved 23-Dec-2025 for the treatment of anemia in adults with alpha- or beta-thalassemia. Agios Pharmaceuticals.
FDA Link Myqorzo (aficamten): Approved 19-Dec-2025 for symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Includes a Boxed Warning for heart failure risk. Cytokinetics, Inc.
FDA Link Fesilty (fibrinogen, human-chmt): Approved 19-Dec-2025 for acute bleeding in patients with congenital fibrinogen deficiency. Octapharma.
FDA Link Rybrevant Faspro (amivantamab and hyaluronidase-lpuj): Subcutaneous formulation approved 18-Dec-2025 for EGFR-mutated non-small cell lung cancer (NSCLC). Johnson & Johnson.
FDA Link Exdensur (depemokimab-ulaa): Approved 16-Dec-2025 as the first ultra-long-acting IL-5 antagonist for severe eosinophilic asthma (administered twice yearly). GSK.
FDA Link Nuzolvence (zoliflodacin): Approved 12-Dec-2025 for uncomplicated urogenital gonorrhea. First-in-class oral antibiotic for MDR strains. Innoviva.
FDA Link Lerochol (lerodalcibep-liga): Approved 12-Dec-2025 to reduce LDL-C in adults with hypercholesterolemia. LIB Therapeutics.
FDA Link Uplizna (inebilizumab-cdon): Label expansion approved 11-Dec-2025 for generalized Myasthenia Gravis (gMG) in AChR+ and MuSK+ patients. Amgen.
FDA Link Waskyra (etuvetidigene autotemcel): Approved 09-Dec-2025 as the first gene therapy for Wiskott-Aldrich Syndrome. Rocket Pharmaceuticals.
FDA Link Breyanzi (lisocabtagene maraleucel): Approved 04-Dec-2025 as the first CAR T-cell therapy for relapsed/refractory marginal zone lymphoma (MZL). Bristol Myers Squibb.
FDA Link
M&A Deals
Pfizer acquires Metsera: $10 billion (Closed Dec 2025). Pfizer beat out Novo Nordisk in a bidding war to secure Metsera’s GLP-1/GIP obesity pipeline.
Source Merck acquires Cidara Therapeutics: $9.2 billion (Announced Dec 2025). Focus on CD388, a universal long-acting antiviral for influenza prevention.
Source Thermo Fisher acquires Clario: $9.4 billion (Announced Dec 2025). Strategic move to integrate high-end clinical-trial endpoint data and analytics.
Source J&J acquires Intra-Cellular Therapies: $14.6 billion (Completed). The largest biopharma deal of the year, securing Caplyta for neuropsychiatric indications.
Source Novartis acquires Avidity Biosciences: $12 billion (Closed Dec 2025). Expands Novartis’ reach into RNA-based therapies for rare neuromuscular diseases.
Source
Clinical Trial Setbacks
Sanofi (tolebrutinib): Discontinued development for Primary Progressive Multiple Sclerosis (PPMS) after Phase 3 PERSEUS trial failed to meet the primary endpoint of delaying disability progression (Dec 15, 2025).
Source Kamada Pharmaceuticals: Terminated Phase 3 trial for Inhaled AAT (Alpha-1 Antitrypsin) in December following a futility analysis.
Source NIH Funding Freeze: In Dec 2025, federal budget constraints led to a pause in roughly 3.5% of all NIH-funded active trials, affecting approximately 74,000 enrolled patients.
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Technological Breakthroughs
FDA Qualifies First AI Drug Development Tool (DDT): On Dec 8, 2025, the FDA officially qualified an AI-driven tool for patient stratification in MASH (formerly NASH) trials, marking a regulatory milestone for generative AI in trial design.
Source Edge AI for Patient Monitoring: New data from Jan 2026 suggests "Edge AI" wearables (processing data on-device) reduced data latency in decentralized trials by 40%, significantly improving remote patient safety monitoring.
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Market Insights
The 2026 "Patent Cliff": Major expiries for blockbusters like Keytruda and Darzalex are projected to trigger a $230 billion revenue loss by 2030, fueling the current surge in aggressive, late-stage M&A.
Source Oncology Shift: While oncology still leads M&A volume, deal values in Neuroscience and Metabolic (Obesity/MASH) diseases have surpassed oncology for the first time in five years as of Q4 2025.
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Summary Table: Recent Major FDA Actions
| Brand Name | Active Ingredient | Company | Indication | Approval Date |
| Nereus | Tradipitant | Vanda | Motion Sickness (Vomiting) | 30-Dec-2025 |
| Yartemlea | Narsoplimab | Omeros | HSCT-TMA | 24-Dec-2025 |
| Aqvesme | Mitapivat | Agios | Thalassemia Anemia | 23-Dec-2025 |
| Myqorzo | Aficamten | Cytokinetics | Obstructive HCM | 19-Dec-2025 |
| Exdensur | Depemokimab | GSK | Severe Eosinophilic Asthma | 16-Dec-2025 |
| Nuzolvence | Zoliflodacin | Innoviva | Gonorrhea | 12-Dec-2025 |
| Lerochol | Lerodalcibep | LIB Therapeutics | Hypercholesterolemia | 12-Dec-2025 |
| Waskyra | Etuvetidigene | Rocket Pharma | Wiskott-Aldrich Syndrome | 09-Dec-2025 |
| Breyanzi | Liso-cel | BMS | Marginal Zone Lymphoma | 04-Dec-2025 |
