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News
Mitapivat Just Rewrote the Treatment Floor for Transfusion-Dependent Thalassaemia, Here’s What the ENERGIZE-T Data Actually Mean
3+ hour, 28+ min ago (861+ words) The Clinical Trial Vanguard Mitapivat Just Rewrote the Treatment Floor for Transfusion-Dependent Thalassaemia, Here’s What the ENERGIZE-T Data Actually Mean Picture the patient record that has defined thalassaemia care for decades: a transfusion schedule, printed or scrolling across a clinic…...
When the ER Is Not an Option: Milestone’s CMO on Bringing AFib Rate Control Home
3+ day, 1+ hour ago (418+ words) The FDA approval of etripamil for PSVT occurred in December, 2025. Investigation about a potential role of etripamil in highly symptomatic AFib, The ReVeRA-Phase 3, trial is another test: can this self-administered nasal spray put an all-too-frequent emergency department problem back in…...
Tyra Selects 60mg Dose of Dabogratinib in NMIBC Phase 2 Study
3+ day, 4+ hour ago (344+ words) The Clinical Trial Vanguard Tyra Selects 60mg Dose of Dabogratinib in NMIBC Phase 2 Study Sixty milligrams once daily: that is the dose Tyra Biosciences selected from SURF302 after the Phase 2 study returned its first results on September 9, and the choice carries real…...
FDA Grants Priority Review to Roche’s Enspryng for MOGAD
3+ day, 4+ hour ago (349+ words) The Clinical Trial Vanguard FDA Grants Priority Review to Roche’s Enspryng for MOGAD A 68% reduction in relapse risk is the number that earned Enspryng its second FDA fast-track designation. The agency granted Priority Review to Roche’s supplemental BLA for satralizumab…...
Seismic Pharmaceuticals Enrolls First Patient in Phase 3 Trial of Istaroxime for Cardiogenic Shock
3+ day, 4+ hour ago (386+ words) The Clinical Trial Vanguard Seismic Pharmaceuticals Enrolls First Patient in Phase 3 Trial of Istaroxime for Cardiogenic Shock Cardiogenic shock kills roughly half the patients it reaches in the ICU, a mortality burden that has persisted for decades without a single…...
DYNAMIKA™: The Operating System for Imaging Clinical Trials
3+ day, 21+ hour ago (542+ words) Six trials. Six imaging platforms. Six disconnected databases. This is not a hypothetical scenario. It is the default operating model for most biotech sponsors running concurrent imaging programs today. And it is why, when something goes wrong, whether in site…...
BridgeBio Shifts BBO-8520 Focus to KRAS Combinations in Second-Line NSCLC
4+ day, 4+ hour ago (322+ words) The Clinical Trial Vanguard BridgeBio Shifts BBO-8520 Focus to KRAS Combinations in Second-Line NSCLC A 63% objective response rate from a Phase 1 monotherapy arm is an unusual number to anchor a strategic pivot on, but that is what BridgeBio Oncology Therapeutics…...
A 25% Sample Size Cut Sounds Like a Win, Until You See the Amendment Queue
4+ day, 3+ hour ago (790+ words) The Clinical Trial Vanguard A 25% Sample Size Cut Sounds Like a Win, Until You See the Amendment Queue A clinical operations lead gets the news from her biostatistics team: the new digitally enhanced composite endpoint just cut the required sample…...
Fresenius Got a Warning Letter Six Months After the Complaints Started. That Gap Is the Real Problem.
5+ day, 3+ hour ago (851+ words) clinicaltrialvanguard.com Fresenius Got a Warning Letter Six Months After the Complaints Started. That Gap Is the Real Problem. The warning letter landed on August 25, 2026, addressed to Fresenius USA Manufacturing, Inc., doing business as Fresenius Medical Care North America Ogden…...
FDA Guidance Expands Cancer Trial Eligibility, Reshaping Feasibility Models
1+ week, 4+ hour ago (383+ words) The Clinical Trial Vanguard FDA Guidance Expands Cancer Trial Eligibility, Reshaping Feasibility Models Forty percent of Phase III cancer trials explicitly barred patients with an ECOG performance status of 2 or higher, and among trials that allowed those patients, they made…...