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.
Overton FDA Hearing Tests Scientific Independence
Heidi Overton's FDA confirmation hearing exposed sweeping advisory committee cuts, tobacco industry ties, and unclear stances on vaccines and mifepristone policy.
What Changes in EMA GVP Module III Revision 2?
GVP Module III Revision 2 took effect on 10 September 2026. See what changes for subcontractor oversight, PSMF access, remote inspections, and risk planning.
Clinical Trials in Depression Reveal New R&D Priorities in 2026
Clinical trials in depression reveal a broader R&D landscape, from antidepressants and NMDA approaches to biological data and precision psychiatry.
Ivonescimab Challenges Keytruda Beyond China
Ivonescimab beat pembrolizumab in a Chinese trial. Pharmatica examines what HARMONi-2 means for global clinical development, trial design, and NSCLC treatment.