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…
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…
Introduction: Aduhelm aducanumab drug is a medication in an injectable form that contains Aducanumab 170mg ml (100mg/ml). It is used to treat Alzheimer’s disease. Aducanumab is a monoclonal antibody. It targets the amyloid protein that clumps into plaques in…
What are the ICH Guidelines? ICH stands for International Conference on Harmonisation, which is a committee that provides a framework for the stability of products in the pharmaceutical industry. ICH guidelines are adopted by every country in the world for…
USFDA approval is a big milestone for any pharmaceutical manufacturing facility. If you are looking to export medicines to the US then you must have your facility approved by the USFDA. A pharma company can only sell direct products in…