Dyne Announces Promising Phase 3 HARMONIA Trial for DM1
A 48-week, global, randomized, placebo-controlled Phase 3 trial in myotonic dystrophy type 1 will enroll approximately 150 participants aged...
New Positive Results for Z-rostudirsen in DMD DELIVER Trial
Dyne Therapeutics reported 24-month analyses from the Phase 1/2 DELIVER trial showing improvements from baseline in lung function (FVC...
Dianthus to Discuss Interim Phase 3 CIDP Trial Results
Dianthus Therapeutics will present an interim responder analysis from Part A of its Phase 3 CAPTIVATE trial evaluating claseprubart...
Rhythm Pharma Sees Positive Phase 3 Setmelanotide Trial Data
Setmelanotide delivered an 18.8% placebo‑adjusted difference in BMI reduction at 52 weeks in the Phase 3 TRANSCEND trial’s expanded...
New VIBRANT Trial Data on Verekitug for Chronic Nasal Polyps
Placebo-adjusted reductions in endoscopic nasal polyp score reached -1.95 (p < 0.0001) at Week 24 under a worst-observation carried-forward...
First Participants Enrolled in Spryte Medical’s InSyte Trial
Spryte Medical has enrolled the first participants in INSYTE, an FDA-approved IDE study evaluating a neuro-specific intravascular optical coherence...
Pharmala Signs Deal for MDMA PTSD Trial in First Responders
PharmAla Biotech has executed a supply-and-data agreement to provide its cGMP MDMA (LaNeo) for an open-label Phase 2 trial...
CRISPR T-Cell Therapy for Solid Tumors Enters Clinical Trial
T-knife Therapeutics has received European authorization of its Clinical Trial Application to initiate ATLAS, an adaptive, first-in-human, open-label Phase...
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...