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…
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…
U.S. Food and Drug Administration approved the most awaited obesity drug Wegovy which contains Semaglutide 2.4 mg in injection form. As per the U.S. FDA, the medicine is advised once a week for chronic weight loss management. In patients with…
The Medicines and Healthcare Products Regulatory Agency (MHRA) is a government agency in the United Kingdom. MHRA’s prime role is to regulate medicines, medical devices, and blood components for transfusion in the UK. MHRA guidelines are very important recommendations 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…
FDA guidelines for high-purity water system The FDA guidelines are dominating the aspect of microbiological conditions of water for injection and purified water systems that are used in the manufacturing of drug products. The guideline also covers the different types…
Title 21 CFR and Its Recommendations The title 21 CFR is a part of the Code of Federal Regulations (CFR) permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. It is allocated…