Daily Dose - May 1st, 2026
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May 1, 2026
FDA’s proposed plausible mechanism framework presents CMC challenges
The framework for the development and approval of individualized therapies for genetic conditions has significant chemistry, manufacturing, and controls hurdles.
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PharmaLogic launches radiopharmaceutical manufacturing site in Georgia
The Atlanta facility, equipped with PET production technology, expands U.S. production capacity and distribution of time-sensitive imaging agents.
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Ecolab opens bioprocessing lab in South Korea for downstream development
The Dongtan facility, the company’s first in Asia, expands regional access to purification studies and process optimization support.
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