Sanofi is gearing up to address the rising demand for its respiratory syncytial virus (RSV) antibody drug, Beyfortus, by leveraging a recently approved manufacturing line. The company's proactive measures aim to ensure that there is no repeat of last year's shortages, which created significant
The recent decision by the Supreme Court to overturn the Chevron doctrine marks a significant shift in administrative law, with profound implications for the healthcare industry, particularly for federal regulators like the FDA (Food and Drug Administration) and the CMS (Centers for Medicare &
In a significant milestone for the biopharmaceutical industry, AGC Biologics' Seattle site successfully underwent a multi-product inspection by the U.S. Food and Drug Administration (FDA) in March 2024. This comprehensive evaluation was aimed at supporting Biologics License Applications (BLA) for
The article delves into the escalating scrutiny by US lawmakers on Chinese biotech and medtech companies, which they allege pose significant national security risks. These legislative actions are part of a broader strategy to curb Chinese influence and secure US technology and intellectual
The FDA's Center for Drug Evaluation and Research (CDER) has embarked on a robust modernization initiative to transform its New Drug Regulatory Program (NDRP). Launched in 2017, this comprehensive effort aims to enhance the efficiency and effectiveness of CDER processes in response to
The FDA's New Drug Regulatory Program (NDRP) within the Center for Drug Evaluation and Research (CDER) has undergone substantial modernization efforts since its launch in 2017. Aimed at enhancing the efficiency and effectiveness of CDER processes in light of advances in genetic science,
