Multiple myeloma, a complex and challenging hematologic malignancy, continues to pose significant therapeutic hurdles, particularly for patients with relapsed or refractory disease. Despite advancements in treatment, a substantial unmet need persists for patients who have exhausted conventional therapeutic avenues. The…
For those living with the constant uncertainty of hereditary angioedema (HAE), a significant breakthrough has arrived. A new treatment, Andembry® (garadacimab-gxii), was recently approved by the U.S. Food and Drug Administration (FDA) on June 16, 2025, offering a powerful new…
Ibtrozi™ (taletrectinib) is a next-generation, oral ROS1 tyrosine kinase inhibitor (TKI), approved by the U.S. FDA on June 11, 2025. It’s designed to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor ROS1…
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…