A few of the key examples from 2025 were:

• Linvoseltamab-gcpt (Lynozyfic) – Linvoseltamab-gcpt (Lynozyfic) was granted FDA accelerated approval on July 2, 2025, for the treatment of relapsed or refractory multiple myeloma in patients who have received at least four prior lines of therapy. It is a BCMA × CD3 bispecific T-cell engager designed to redirect T-cells to target malignant plasma cells. This approval further strengthens the growing class of off-the-shelf immunotherapies in heavily pretreated multiple myeloma, offering an additional treatment option for patients with limited alternatives.
• Datopotamab deruxtecan-dlnk (Datroway) – Datopotamab deruxtecan-dlnk (Datroway) received accelerated approval use in June 2025 for advanced solid tumors, including EGFR-mutated non-small cell lung cancer after prior therapy. It is a TROP2-directed antibody–drug conjugate (ADC) that delivers cytotoxic payload directly to tumor cells. This approval further reinforces the growing dominance of ADCs in solid tumor treatment and expands precision oncology options for patients with resistance to EGFR-targeted therapies.
• Clesrovimab-cfor (Enflonsia) – dClesrovimab-cfor (Enflonsia) was approved in June 2025 for the prevention of RSV lower respiratory tract disease in infants. It is a long-acting monoclonal antibody designed to provide passive immunity against respiratory syncytial virus during early childhood. This approval expands the pediatric infectious disease prevention toolkit and adds a new option within the growing landscape of RSV prophylaxis strategies.
• Taletrectinib (Ibtrozi) – Taletrectinib (Ibtrozi) was approved in June 2025 for the treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer. It is a next-generation targeted kinase inhibitor designed to improve outcomes in patients with ROS1 rearrangements, including enhanced activity against central nervous system metastases. This approval provides a more effective treatment option in a setting where durable systemic and intracranial control remains a key clinical challenge.
• Garadacimab (Andembry) – Garadacimab (Andembry) was approved in June 2025 for the prevention of hereditary angioedema attacks. It is a monoclonal antibody that inhibits Factor XIIa, targeting the disease pathway at an upstream point in the kallikrein–kinin system. This approval represents a novel therapeutic strategy that enhances control of HAE by intervening earlier in the inflammatory cascade, offering improved prophylactic management options for patients.
• Nipocalimab (Imaavy)- Nipocalimab (Imaavy) was approved in April 2025 for the treatment of generalized myasthenia gravis. It is an FcRn blocker that reduces pathogenic IgG antibodies by inhibiting neonatal Fc receptor–mediated recycling. This approval expands the FcRn inhibition class in autoimmune disease management, offering an additional therapeutic option alongside existing agents such as efgartigimod.
• Suzetrigine (Journavx)- Suzetrigine (Journavx) was approved in January 2025 for the treatment of moderate to severe acute pain. It is a first-in-class NaV1.8 sodium channel inhibitor that targets pain signaling pathways without acting on opioid receptors. This approval represents a major advancement in non-opioid analgesia, offering a novel option for pain management amid ongoing efforts to reduce reliance on opioid-based therapies.
• Aficamten (Myqorzo)- Aficamten (Myqorzo) was approved in December 2025 for the treatment of symptomatic obstructive hypertrophic cardiomyopathy. It is a cardiac myosin inhibitor that works by reducing excessive contractility in the heart muscle, thereby improving hemodynamic function. This approval strengthens the emerging class of targeted cardiomyopathy therapies, offering a new treatment option in a rapidly evolving area of cardiovascular medicine.