17+ hour, 22+ min ago  (386+ words) The Clinical Trial Vanguard Teva Submits NDA for Ecopipam in Pediatric Tourette Syndrome Aripiprazole's FDA approval for pediatric Tourette syndrome came in December 2014, meaning a full decade has passed without a new option entering the space. Teva's NDA submission for…...

17+ hour, 22+ min ago  (429+ words) The Clinical Trial Vanguard Connect Biopharma Completes Enrollment in Rademikibart Asthma Study The real design bet Connect Biopharma is making with Seabreeze STAT is not whether rademikibart works in chronic asthma " that territory belongs to dupilumab, approved for add-on maintenance…...

17+ hour, 24+ min ago  (793+ words) The Clinical Trial Vanguard An Open Letter to Acting Commissioner Diamantas: The FDA Needs a Regulatory Pathway for Vaccine-Based Dementia Prevention Trials Now Dear Acting Commissioner Diamantas, A paper published this month in Nature Medicine lays out one of the…...

2+ day, 17+ hour ago  (904+ words) The Clinical Trial Vanguard The FDA's Bayesian Guidance Sounds Like Good News for Sponsors. Sites Will Feel It Differently. A site coordinator at a mid-volume oncology center gets a call from her CRA in the middle of enrollment. The interim…...

2+ day, 17+ hour ago  (807+ words) The Clinical Trial Vanguard Closed-Loop DBS Just Validated a New Class of CNS Trial Design. Is Your Protocol Ready? A neurologist at UCSF pulls up the June 15, 2026 issue of Nature Medicine and sees a number that should unsettle every CNS…...

2+ day, 17+ hour ago  (336+ words) The Clinical Trial Vanguard Ligufalimab Plus Azacitidine and Venetoclax Shows OS Benefit in AML Phase II The underlying backbone here matters. Azacitidine plus venetoclax received FDA approval for this exact population and has become the established standard of care, with…...

3+ day, 12+ hour ago  (280+ words) The post triggered a convergence. Within hours, two other credible clinical operations voices were publishing their own versions of the same uncomfortable argument. The overlap was not coordinated. That is what makes it significant. What these practitioners are describing is…...

3+ day, 17+ hour ago  (403+ words) The Clinical Trial Vanguard Selinexor-Ruxolitinib Combination Meets Primary Endpoint in Myelofibrosis Trial The hazard ratio that will dominate conversations at EHA 2026 is 0. 43: a more than 50 percent reduction in the risk of death observed in the combination arm of the phase…...

3+ day, 17+ hour ago  (486+ words) The Clinical Trial Vanguard Trans Con PTH Maintains Response in 86% of Hypoparathyroidism Patients at 3. 5 Years Three and a half years into a clinical trial, 86 percent of adults with hypoparathyroidism still met a demanding, multi-component response definition that required normal serum…...

3+ day, 17+ hour ago  (828+ words) The Clinical Trial Vanguard Jazz and Pharma Mar Just Ran Out of Runway: Zepzelca's Confirmatory Failure Is an Accelerated Approval System Under Stress Six years ago, a single-arm study of 105 patients with metastatic small cell lung cancer gave Jazz Pharmaceuticals…...