Cover storyExplore how pharma leaders can build governed AI systems that improve manufacturing without compromising quality or accountability.
Sutro Biopharma doses first patient in Phase 1 STRO-006 trial, its DAR8 ITGB6-targeting ADC built on site-specific cell-free conjugation.
FDA accepts Unicycive's OLC NDA resubmission as Class II with a March 25, 2027 PDUFA date, following a CMC vendor switch after two CRLs.
Abbott plans to spin off its $8.5B Nutrition unit by end-2027, separating 14 manufacturing sites into a standalone public company.
FDA issues Import Alert 89-04 against Olympus Medical Systems, blocking U.S. entry of six endoscopic device categories over unresolved Quality System violations.
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