The MASAI Trial Just Made AI-Augmented Mammography the Standard of Care. The FDA Hasn’t Noticed
The MASAI trial showed AI-plus-one-radiologist outperforms two radiologists in breast cancer screening. FDA's AI device framework still treats this...
France Just Approved What the U.S. Still Won’t Name: IV Ketamine for Acute Suicidal Crisis
France's March 2026 approval of intravenous racemic ketamine for severe suicidal crisis is the first regulatory action of its...
The Liver Signal Europe Just Sent About Cenobamate Will Reshape How Sponsors Design Post-Approval Safety Plans
The EMA's PRAC issued a direct communication to healthcare professionals about severe liver injury linked to cenobamate in April...
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...
Inhibikase Enrolls First Patient in Phase 3 PAH Study
IMPROVE-PAH is a two-part adaptive Phase 3 program testing IKT-001, an oral prodrug of imatinib, in up to 180...
Incyclix Bio’s Hope: A Surging $5M for Cancer Trial
Incyclix Bio secured an additional $5 million extension to its Series B from Hatteras Venture Partners to advance INX-315,...
COACH trial: hGH accelerates CNP benefits in achondroplasia
At Week 52 in the Phase 2 COACH trial, once-weekly TransCon CNP plus once-weekly TransCon hGH delivered a mean...
Radiopharm Advances to Cohort 3 in Phase 1 Clinical Trial
Radiopharm Theranostics’ Phase 1 HEAT trial cleared its second safety gate, with the independent monitoring committee recommending dose escalation...
Incyclix Bio’s Promising Cancer Trial Gets New $5M Fund
Incyclix Bio secured an additional $5 million for its Series B to extend development of INX-315, a selective CDK2...
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 —...