Why clinical biomarkers face a slow climb before regulators accept them as surrogate endpoints
Biomarkers can speed drug approvals, but weak validation can haunt sponsors. FDA and EMA are tightening the path from signal to endpoint.
What Clene Inc.’s FDA feedback reveals about the future of surrogate endpoints in ALS trials
Can biomarker-driven approvals transform ALS drug development? Explore how Clene Inc.’s FDA feedback on CNM-Au8 could accelerate innovation.
Partner Therapeutics’ zenocutuzumab data adds nuance to progression-driven treatment decisions in NRG1-positive lung cancer
Find out how zenocutuzumab treatment beyond progression could change care for NRG1 fusion-positive lung cancer and what clinicians should watch next.
Why Deciphera Pharmaceuticals’ tirabrutinib NDA matters for the future of CNS lymphoma therapy
FDA accepts tirabrutinib NDA for relapsed or refractory PCNSL. Find out what this means for CNS lymphoma treatment and regulatory strategy.
Diamyd Medical fast-tracks type 1 diabetes Phase 3 trial after FDA alignment on earlier efficacy readout
Find out how Diamyd Medical is accelerating its type 1 diabetes Phase 3 trial after FDA alignment—what this means for approval, adoption, and risk.