Dublin, Jan. 29, 2026 (GLOBE NEWSWIRE) -- The "Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products Training Course (Apr 23rd - Apr 24th, 2026)" training has ...
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 ...
White Oak, Md., Jan. 12, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced it is sharing information about the agency’s flexible approach to overseeing chemistry, ...
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 ...
CERo Therapeutics received FDA approval for its IND CMC amendment, crucial for starting CER-1236 patient dosing. The phase 1 trial will assess CER-1236's safety and efficacy in relapsed or refractory ...
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 ...
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 ...
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