Modernizing infrastructures, record drug approvals, and harmonization were all positive regulatory advancements in July 2026.

David S. Thompson, CSAP, is Chief Alliance Officer at Eli Lilly and Company.

This week’s content included Moderna's mRNA flu approval, CMO governance tips, OSTP’s deregulation push, a $2 billion oncology license, and July's regulatory wrap-up. In the first week of August, ...

FDA authorized mFlusiva for adults 50–65 and ≥65, contingent on an additional confirmatory trial in older adults, with commercial availability targeted for the 2026–2027 flu season. A large outcomes ...

OSTP's July 2026 report to Trump diagnoses U.S. science slowdown and pushes deregulation, new funding models, reshoring, and AI-driven "Genesis Mission." Much of the report is broad science policy: ...

Atul Mohindra is vice president of R&D for Lonza Integrated Biologics where he brings more than 20 years of experience in cell biology, bioprocessing, media development, and process scale up ...

Orexin neuron loss drives narcolepsy type 1’s multisymptom phenotype, and historical management has been symptom-by-symptom rather than deficit-correcting, leaving underlying biology untreated. Orexin ...

AI tools have arrived, but organizational readiness, data governance, and regulatory gaps now limit real-world impact. Six months after industry experts laid out their predictions for 2026, many of ...

Leading manufacturers now deploy validated agentic AI that detects OOS events, retrieves batch records, correlates prior deviations, and drafts RCA packages, yielding ≥50% faster investigations.

Pressure-rated retention agitation can preserve batch uniformity through storage/unloading, mitigating settling and phase separation under elevated temperature and pressure common to reactive ...

Across development, manufacturing, quality, and outsourcing, the pharma industry is being asked to scale complexity without sacrificing control. Pharmaceutical manufacturing is entering a phase ...