Co-ordinated EU GMP Inspection Guidelines: What You Need to Know
New EU GMP inspection guidelines take effect in September 2026. Here is what you need to know about joint inspections, planning, and reporting.
More Than Conjugation: ADC Manufacturing
ADC manufacturing is becoming more complex as payloads, conjugation, lyophilisation, containment, and scale-up reshape CMC strategy and commercial readiness.
Inside the GMP Inspection Process, Explained
We map the GMP inspection process end to end, showing what regulators check, who is responsible, and where compliance often breaks down.
AI Bioweapons Risk Grows as Agent Safeguards Fail
The AI bioweapons risk has entered a new, more worrying phase as Moonshot AI’s Kimi’s jailbreak exposes gaps in agent safeguards.
FDA Expedited IND Pilot Targets Faster First-In-Human Trials
The FDA’s Expedited IND Pilot introduces rolling review and sponsor-QRI partnerships to accelerate Phase I first-in-human trials while retaining regulatory oversight.
FDA Non-Animal Testing Policy Expands Nonclinical Options
FDA non-animal testing policy expands the regulatory role of nonclinical methods and introduces 25 NAM use cases for pharma development teams.