On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support (CDS) ...
The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual disease (MRD) and complete response (CR) as primary end points in clinical ...
The Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) today released the sDHT Adoption Navigator, a comprehensive educational resource designed to help ...
Registrar Corp, the world's largest food and beverage regulatory compliance provider, today announced its acquisition of TechniCAL, the world's leading independent Process Authority for low-acid and ...
Detailed price information for Aquestive Therapeutics Inc (AQST-Q) from The Globe and Mail including charting and trades.
Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged sword." ...
In a year from now, progress is to be measured in the institutionalisation of the approach with greater regulatory acceptance ...
Data integrity is key to the success of any cell therapy program. CDMOs can implement robust data management systems for ...
Discusses FDA Complete Response Letter and Next Steps for Anaphylm Epinephrine Sublingual Film February 2, 2026 8:00 ...
Artificial intelligence (AI) is now an essential tool in biopharma manufacturing, yet industry still needs guidelines on how LLMs, ML, and other technologies should be used in drug making, say the ...
Deficiencies limited to packaging and administrationCompany believes it can rapidly resolve deficiencies and expects to resubmit as early as Q3 2026Remains well-capitalized and anticipates ending 2026 ...
Many organizations are operating with constrained resources while trying to expand, launch new therapies, or scale ...
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