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Manufacturing
FDA’s first AI-focused cGMP warning letter signals new scrutiny for manufacturers
The FDAs enforcement action against Purolea Cosmetics Lab offers an early look at how the agency expects AI-generated work to fit within existing quality systems, with experts saying human oversight and quality controls remain essential.
July 16, 2026
·
3 min read
·
John Potter
Press Releases
Nucleai Expands its Strategic Partnership with University of Glasgow to Advance Access to Its Multimodal Tissue Intelligence AI Platform
July 16, 2026
·
3 min read
Press Releases
CareDx to Report Second Quarter 2026 Financial Results on July 30, 2026
July 16, 2026
·
1 min read
Press Releases
Niagen Bioscience Appoints Abhijit Kale, Ph.D., as Senior Director of Global External Research
July 16, 2026
·
6 min read
Press Releases
CareDx Announces Finalization of Solid Organ Transplant Molecular Testing Local Coverage Determination
July 16, 2026
·
3 min read
Press Releases
Transcat to Host First Quarter Fiscal Year 2027 Conference Call and Webcast on Tuesday, August 4, 2026 at 4:30 p.m. Eastern Time
July 16, 2026
·
4 min read
Press Releases
Tempus Highlights Landmark Publication Demonstrating Safe, Real-World Deployment of Paige Prostate AI Suite in the UK National Health Service
July 16, 2026
·
6 min read
Press Releases
FDA Accepts Shionogi’s sNDA for Fetroja® (cefiderocol) for Use in Pediatric Patients with Serious Infections Caused by Susceptible Gram-negative Bacteria
July 16, 2026
·
6 min read
Press Releases
Harmony Biosciences Preannounces Record Quarterly Revenue for Q2 2026, Reaffirms Full-Year 2026 Revenue Guidance, and Announces CFO Transition
July 16, 2026
·
5 min read
Press Releases
Crown Bioscience Joins C-Path’s NAMs Developer Coalition to Advance Human-Relevant Models in Drug Development
July 16, 2026
·
3 min read
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