Title: Advancements in Cell Cultivation: A Chemically Defined and Xeno-Free Culture System Introduction: Cell culture has revolutionized various fields of...
Otsuka’s Hereditary Angioedema Drug Set to be Commercialized in Europe Hereditary angioedema (HAE) is a rare genetic disorder characterized by...
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recently approved three new drugs for use...
European Regulators Advocate for Approval of Biogen and CRISPR Drugs In a significant development for the biotechnology industry, European regulators...
How to Plan for a Successful EMA Policy 0070 Submission The European Medicines Agency (EMA) Policy 0070 is a regulatory...
A Comprehensive Guide to Understanding the Evidence Utilized in Drug Product Withdrawals Drug product withdrawals occur when a pharmaceutical company...
Updates on EMA Pharmacovigilance Regulations Pharmacovigilance is a crucial aspect of drug regulation and patient safety. It involves the monitoring,...
A Guide to Managing Phase 1 Clinical Studies in BioPharma Services Phase 1 clinical studies play a crucial role in...
European regulators are taking a closer look at GLP-1 drugs, seeking further information on the potential risks associated with these...
The pharmaceutical industry has come a long way since its inception, constantly evolving and redefining drug development. Over the years,...
European Cystic Fibrosis Medicine Approval Granted to Vertex Vertex Pharmaceuticals, a leading biotechnology company, has recently received approval from the...
Comparing Apellis’ Syfovre and Astellas’ Izervay: A Comparison of Geographic Atrophy Treatments Geographic atrophy (GA) is a progressive and irreversible...
Title: A Comprehensive Guide to Validating and Verifying Medical Devices by Johari Digital Healthcare Ltd. Introduction: Medical devices play a...
Decentralized clinical trials (DCTs) have gained significant attention in recent years due to their potential to improve patient access, reduce...
The European Medicines Agency (EMA) has recently released guidance on the minimum criteria for reporting adverse reactions. This guidance aims...
