Semaglutide Just Passed Its Hardest Test Yet — And the FDA Has No Roadmap for What Comes Next
A landmark Lancet RCT shows once-weekly semaglutide cut heavy drinking days in 108 AUD-plus-obesity patients. The FDA approval path...
Moe Alsumidaie
The Eight Hours Clinicians Ignored: How Albus Health Is Turning Sleep Into a Clinical Endpoint
Mikesh Udani CEO, Albus Health For decades, respiratory medicine has measured what patients do during the day—spirometry in clinic,...
The Disease-Modification Bet in Pulmonary Arterial Hypertension
Sten R. Sörensen CEO and Board Member, Cereno Scientific Pulmonary arterial hypertension kills most patients within seven years of...
NMN in ITP: A Phase 1/2 Signal That Should Rewrite How We Design Rare Disease Trials
A phase 1/2 NMN trial in immune thrombocytopenia just posted a clean safety signal and platelet response data that...
The Process Is the Point: Why One Enterprise Leader Says Pharma Keeps Automating the Wrong Thing
Poonam Rihel Senior Enterprise Leader, R&D Poonam Rihel has watched a decade of digital transformation initiatives in pharma produce...
The 35% Problem: Why Isolate-Based AST Is Systematically Under-Detecting Resistance in Complicated Urinary Tract Infection
The 35% Problem — The Clinical Trial Vanguard The clinician prescribed empirically. The lab report said susceptible. Three weeks...
FDA Real-Time Clinical Trials: Why AI Systems That Update Themselves Are Breaking Clinical Trial Design
FDA's April 2026 real-time clinical trial push exposes a fatal flaw: when AI updates itself mid-study, your protocol is...
Five Approvals, Nine Expansions: What the EMA’s April CHMP Meeting Reveals About Where Global Drug Development Is Heading
EMA's CHMP recommended 5 new medicines and 9 indication expansions in its April 20–23 meeting — here's what the...
BIOMEDE Missed Its Primary Endpoint — And Still Changed Pediatric CNS Trial Design Forever
The BIOMEDE Phase 2 trial in DIPG missed OS superiority but exposed a biomarker-survival link that should rewrite how...
Loper Bright Is Rewriting FDA’s Authority Over Synthetic Biology — Before the Industry Knows It
The Supreme Court's Loper Bright ruling is quietly dismantling FDA's deference-based regulatory hold over synthetic biology, and clinical programs...