CMC Biologics, a global leader in clinical and commercial manufacturing of therapeutic proteins, and River Vision Development Corporation (River Vision), a private company focused on ophthalmology, ...
"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 ...
Discussion to Cover the Importance of Early-Stage CMC Testing in Enhancing Biologic Predictability, Scaling Up, and Accelerating Time to Market KAISERAUGST, Switzerland, April 22, 2025 /PRNewswire/ -- ...
Biologics manufacturers urged to develop a chemistry, manufacturing, and controls (CMC) management strategy for reference material early.
Recognized as Biologics CDMO of the Year, BioDlink shares insights into the world's first approved EGFR-targeted ADC for recurrent/metastatic nasopharyngeal carcinoma The company enables seamless ...
* Portola Pharmaceuticals- pursuant to agreement, cmc will provide other services supporting co's regulatory applications in United States, European Union * Portola Pharmaceuticals Inc- under ...
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