TrialAssure’s ANONYMIZE platform has been selected by the European Medicines Agency as an official...
Author - Abby Davey
Acrosian launches as AI-era biometrics CRO for life sciences...
Acrosian has launched as a biometrics contract research organisation focused on AI-augmented...
AI in biotechnology moves from promise to operating reality
Artificial intelligence is moving from experimental use case to core infrastructure across...
PumasAI supports launch of India computational lab for AI in...
PumasAI has helped establish a new computational laboratory in India focused on artificial...
Kivo to join RAPS panel on real-world AI use in life sciences
Kivo will join a panel of life sciences and regulatory experts at an upcoming Regulatory Affairs...
Trutakna wins FDA accelerated approval for IgA nephropathy on...
The US Food and Drug Administration has granted Trutakna accelerated approval to reduce proteinuria...
Casgevy gene therapy approved for children aged two and older...
The US Food and Drug Administration has approved expanded use of the Casgevy gene therapy for...
Beyond the Lab: How AI is Recalibrating the Economics and...
Drug development has long been defined by its brutal economics: an average of 10 to 15 years from...
FDA and EMA Rules for AI in Drug Development: What Companies...
The FDA and EMA regulate AI in drug development through a risk-based, lifecycle approach: AI used...
GxP-Compliant AI: Validating Machine Learning for Regulated Drug...
GxP-compliant AI is artificial intelligence built, validated and monitored to meet the “Good...