The UK’s AI Biosecurity Lab Puts Pharma at the Centre of Security
The UK AI Biosecurity Lab brings government, AI developers, and life sciences together to detect biological threats and accelerate medical countermeasures.
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.
New Targets for Type 2 Diabetes Treatment?
Development of new treatments for people with type 2 diabetes has reached far beyond glucose control. See the new targets, GLP-1 advances, and challenges for development.
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.
The FDA Rare Disease Framework Initiative Explained
The FDA Rare Disease Framework Initiative aims to make rare disease drug review more consistent. Explore the six commitments and what sponsors should do now.