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)…
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…
Urinary tract infections (UTIs) are among the most common bacterial infections worldwide, which cause issues to millions of women every year. While first-line agents like nitrofurantoin and trimethoprim-sulfamethoxazole have long dominated treatment paradigms, rising resistance and tolerability issues underscore the…
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…
The Central Drugs Standard Control Organization (CDSCO) has released the “Not of Standard Quality” NSQ drugs alert for October 2024. This monthly update aims to inform stakeholders about pharmaceutical products that have failed to meet quality standards. It is an…