Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees ...

Data Monitoring Committees (DMCs) play a pivotal role in safeguarding participant safety and ensuring the integrity of clinical trials. Operating independently from trial sponsors and ...

The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial ...

Relmada is well capitalized with approximately $54.1 million in cash and cash equivalents as of September 30, 2024 CORAL GABLES, Fla., Dec. 04, 2024 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc ...

An independent data monitoring committee has ruled that a phase 3 clinical trial investigating vidofludimus calcium for relapsing MS may continue as originally planned, according to the ...

SHANGHAI, Feb. 25, 2025 Data Monitoring Committee (DMC) has completed the first safety and efficacy assessment of the global Phase III clinical trial, recommending continued progression as planned ...

Theriva™ Biologics Announces Positive Outcomes from the Second Meeting of the Independent Data Monitoring Committee for VIRAGE, the Company’s Phase 2b Clinical Trial of VCN-01 in Combination ...

News for Uniqure B.V. uniQure Announces Favorable Recommendation from Independent Data Monitoring Committee for its Phase I/II EPISOD1 Clinical Trial of AMT-162 for the Treatment of SOD1-ALS ...

Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company specializing in the development of novel therapies to restore, treat and prevent hearing loss disorders, today ...

Based on these findings, the Independent Data Monitoring Committee recommended the trial stop early. Topline data were announced from a phase 3 trial evaluating tebipenem pivoxil hydrobromide (HBr ...