PHILADELPHIA--(BUSINESS WIRE)-- iECURE, Inc., a clinical-stage genome editing company developing variant-agnostic in vivo targeted gene insertion therapies for the treatment of severe, inherited, ...

Wugen Selected for U.S. FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program to Support Manufacturing Readiness of Soficabtagene Geleucel -- FDA Chemistry, Manufacturing, ...

iECURE, Inc., a clinical-stage genome editing company developing variant-agnostic in vivo targeted gene insertion therapies for the treatment of severe, inherited, neurometabolic disorders, today ...

Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological malignancies, today announced that the U.S. Food and Drug ...

April 23 (Reuters) - Grace Therapeutics said on Thursday the U.S. Food and Drug Administration declined to approve its drug ...

April 23 (Reuters) - Grace Therapeutics said on Thursday the U.S. Food and Drug Administration declined to approve its drug ...

Developing innovative pharmaceutical drugs and technologies is a complicated process. A robust chemistry, manufacturing, and controls (CMC) strategy is critical to determining a new drug’s success or ...

Chemistry, manufacturing, and controls (CMC) is key in drug development, ensuring novel therapeutics’ consistency, quality, and safety. The approval process for new medications can take 10–15 years, ...