“Regulatory flexibility must be tailored for cell and gene therapies,” said FDA Commissioner Marty Makary, M.D., M.P.H. “These are common-sense reforms that will address the unique characteristics of ...

Flow Chemistry continues to gain momentum as a powerful alternative to batch processing, offering improved safety, easier ...

Citius Pharmaceuticals Inc. appointed drug industry veteran Kelly Creighton as executive vice president of chemistry, manufacturing and controls, the company announced Nov. 5. Creighton will be ...

The quality of a drug product is determined by the manufacturing line. Preclinical assessments and clinical trials provide an indication of safety and efficacy, but it is the manufacturing process ...

Chemistry, Manufacturing and Controls (CMC): are all stages of the drug development life cycle, after drug discovery. During preclinical drug development, the proper analytical methods are validated ...

In January 2020, the Food and Drug Administration (FDA) issued a guidance entitled Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications ...

Drug Development needs innovation, creativity, and a multiple disciplinary method in gaining a successful path to approval. A successful program can offer a valuable opportunity for a drug development ...

SAN DIEGO--(BUSINESS WIRE)--Janux Therapeutics, a biopharmaceutical company developing novel T cell engager immunotherapies, today announced the appointment of Charles Winter as Senior Vice President ...