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,
In a significant move within the pharmaceutical manufacturing industry, Veranova has announced a substantial $30 million investment to enhance its Devens, Massachusetts facility. This strategic expansion is designed to bolster Veranova’s capabilities in developing and manufacturing antibody-drug
In a significant move to improve data practices within the biopharmaceutical industry, the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) has partnered with the Open Applications Group (OAGi). This collaboration aims to overcome the prevalent issue of data
Novo Nordisk, a global leader in healthcare solutions for chronic diseases, has embarked on a transformative expansion project in Clayton, North Carolina. This unprecedented $6.8 billion investment aims to significantly ramp up the company's production capacity for injectable treatments, thereby
The collaboration between Abzena and Argonaut Manufacturing Services marks a significant milestone in the biopharmaceutical industry. These two leading Contract Development and Manufacturing Organizations (CDMOs) have embarked on a strategic partnership aimed at offering comprehensive solutions for
