France Approved IV Ketamine for Suicidal Crisis. The FDA Should Be Uncomfortable Right Now.
France's March 2026 authorization of intravenous racemic ketamine for acute suicidal crisis is the first regulatory approval of its...
MRD Is Now the Endpoint That Matters: The EMN24 IsKia Trial Just Proved It
The EMN24 IsKia phase 3 trial didn't just test a new drug combination for newly diagnosed multiple myeloma —...
The Alzheimer’s Prevention Trial Has No Finish Line — Until Now
A new set of target product profiles published in Nature Medicine attempts to define what a successful preventive Alzheimer's...
The POLAR Trial Proves Pancreatic Cancer Trials Were Broken by Design
The POLAR trial's Phase 2 results in homologous-recombination-deficient metastatic pancreatic cancer aren't just a clinical win — they're an...
The FDA Doesn’t Have a GLP-1 Problem. It Has an Evidence Problem.
A trial emulation study of 174,678 type 1 diabetes patients shows GLP-1RAs cut major cardiovascular events and end-stage kidney...
Greenwich LifeSciences Switched Drug Product Mid-Pivotal Trial. The FDA Has Rules About That.
Greenwich LifeSciences announced mid-trial use of commercially manufactured GP2 in its Phase III FLAMINGO-01 study. What looks like a...
How a Single eGFR Change Is Exposing the Clinical Trial Industry’s Embedded Patient Bias Problem
A new real-world evidence study shows that removing race from the kidney function algorithm resulted in 5.3 more transplants...
The UK Just Made a $64M Bet That the U.S. Is Too Distracted to Match
While Washington debates FDA staffing cuts and budget rescissions, the UK's NIHR has made a $64 million structural investment...
Bourla vs. Prasad: Is Pfizer Defending Science or Defending Its Pipeline?
When Pfizer CEO Albert Bourla publicly calls out a sitting FDA division chief by name, the instinct is to...
Why Big Pharma Clinical Trial Digital Transformation Initiatives Fail
The trial lead sat in a high-stakes protocol review meeting, subtly tilting their laptop screen away from the digital...