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 ...

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 ...

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: ...

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 ...

PharmTech spoke with Dr. Hui-Yin (Harry) Li, president and CEO of Wilmington PharmaTech, about steps that should be taken to build a productive relationship between sponsor and contract organizations.

Modernizing infrastructures, record drug approvals, and harmonization were all positive regulatory advancements in July 2026. This month in pharmaceutical regulations, in the United States, the FDA ...

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.

EMA introduced its New Fee Regulation in January 2025, but what impact will the new fees and charges have on medicine developers? On 1 Jan. 2025, the European Medicines Agency (EMA) introduced a new ...

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 ...

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