Olorofim Meets Non-Inferiority Goal in Phase 3 Invasive Aspergillosis Trial
Olorofim meets non-inferiority goal in Phase 3 invasive aspergillosis trial, showing 23.8% mortality versus 24.3% for AmBisome with significantly...
FDA Approves Utebzi, First Oral Carbapenem for Complicated UTIs
FDA approves oral carbapenem Utebzi for complicated UTIs, offering an IV-to-oral step-down option for hospitalized patients with resistant infections.
FDA Accepts Lunsumio and Polivy Combo for Relapsed Refractory B-Cell Lymphoma
FDA accepts Lunsumio and Polivy combo for relapsed refractory B-cell lymphoma, with phase III data showing 11.5-month median PFS...
When the Protocol Keeps Changing: What MAMS Trials Actually Cost Sites to Run
The OCTOPUS progressive MS platform trial has enrolled 700+ participants across dynamic arms. Here's what sites need to know...
Adaptive DBS Just Rewrote the Rules for CNS Trial Design — Is the FDA Ready?
A Nature Medicine randomized trial shows adaptive DBS cuts gait variability in Parkinson's. The real story is what its...
The 95% Problem: Why Clinical AI Keeps Failing — And What It Takes to Actually Fix It
Medable's Andrew Mackinnon on agentic AI adoption, ontology layers, and why waiting to clean your data may cost you...
The Tolerability Bet: Biohaven’s Irfan Qureshi on Why Being Second in a Drug Class Can Still Win
Opakalim cleared 1,000 patients without the CNS side-effect burden that haunted its predecessors. Now the company is betting that...
Ligufalimab Plus Azacitidine and Venetoclax Shows OS Benefit in AML Phase II
Ligufalimab plus azacitidine and venetoclax achieved 78.7% nine-month OS rate in AML, nearly doubling response duration versus standard care...
The FDA’s Bayesian Guidance Sounds Like Good News for Sponsors. Sites Will Feel It Differently.
FDA's January 2026 Bayesian draft guidance promises flexible trial designs — but adaptive interim triggers, real-time IRB amendments, and...
Closed-Loop DBS Just Validated a New Class of CNS Trial Design. Is Your Protocol Ready?
A UCSF randomized trial of adaptive DBS in Parkinson's gait published in Nature Medicine signals a coming wave of...