Did OM1 just prove AI-powered real-world evidence can survive FDA scrutiny?
FDA-grade evidence is getting bigger and harder to collect. OM1’s Hologic study shows how AI may change medtech submissions.
Why Lundbeck’s INFUSE study could broaden how migraine treatment success is measured
Lundbeck’s new Vyepti data highlight migraine-related cognitive symptom gains. Read what the INFUSE study could change for clinicians and the CGRP market.
Real-world data meets legal limits as Bayer targets ERLEADA claims in prostate cancer
Bayer’s lawsuit against Johnson and Johnson raises critical questions about real-world evidence and oncology marketing. Read what this means for drug claims.
What TG Therapeutics’ ACTRIMS strategy signals about the next competitive phase in anti-CD20 multiple sclerosis therapy
Find out how TG Therapeutics’ ACTRIMS strategy reshapes competition in anti-CD20 multiple sclerosis therapy and what clinicians and regulators are watching next.