The U.S. Food and Drug Administration (FDA) has approved ENFLONSIA (clesrovimab-cfor), a groundbreaking preventive monoclonal antibody developed by Merck (MSD outside the U.S. and Canada). This single-dose injectable therapy offers seasonal protection against Respiratory Syncytial Virus (RSV) — a major…
Dry Eye Disease (DED) is a prevalent condition affecting millions worldwide, characterized by insufficient or poor-quality tears leading to ocular discomfort and visual disturbances. On May 28, 2025, the U.S. Food and Drug Administration (FDA) approved Tryptyr™ (acoltremon ophthalmic solution)…
Lung cancer, particularly non-small cell lung cancer (NSCLC), remains one of the deadliest malignancies worldwide. Despite recent therapeutic advancements, many patients with advanced disease still face limited options—especially after failure of first-line systemic therapy. EMRELIS for NSCLC(telisotuzumab vedotin-tllv), a novel…
On May 08, 2025 , the FDA granted accelerated approval to a novel oral therapy for a rare form of ovarian cancer. Avutometinib (a “RAF-MEK clamp” inhibitor) and Defactinib (a FAK inhibitor) are now co-packaged as Avmapki Fakzynja Co-Pack and…
If you are looking for the New Drug List for 2025, approved by the FDA. We worked on the consolidation of the list with helpful links and company details. Novel Drug Approvals for 2025 No. Drug Name/Approval Date Active Ingredient…
Tenosynovial giant cell tumor (TGCT), formerly known as pigmented villonodular synovitis (PVNS), is a rare, non-cancerous joint tumor that causes pain, swelling, and restricted mobility. While surgery has traditionally been the primary treatment, it isn’t always feasible, especially for tumors…
The world has been dependent on opioids for a long time for pain management, which has driven the search for safer, non‐opioid alternatives. The development of JOURNAVX (Suzetrigine) is not less than a groundbreaking medication approved by the FDA on…
The U.S. Food and Drug Administration (FDA) approved Grafapex treosulfan on January 22, 2025, marking a significant advancement in preparative regimens for allogeneic hematopoietic stem cell transplantation (alloHSCT) in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) 310. Developed by Medac GmbH and…
Breast cancer remains one of the most prevalent and challenging cancers worldwide, with over 300,000 new cases diagnosed annually in the United States alone [4] [10]. Among these, hormone receptor-positive (HR+), and HER2-negative breast cancer accounts for approximately 70% of…
Mounjaro (Tirzepatide): A diabetes and weight loss drug Introduction: Diabetes, a chronic metabolic disorder affecting millions of people worldwide, poses severe health challenges and demands effective treatment as soon as possible. The global prevalence of diabetes has been steadily rising…