Yahoo Finance

Independent Data Monitoring Committee Recommends Initiation of Cohort 2 at the Increased Dose of 12 mg/kg in Entrada Therapeutics’ ELEVATE-44-201 Study

BOSTON, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today announced that an independent Data Monitoring Committee (DMC), per study protocol, has reviewed all available ...
JD Supra

How to use a Data Monitoring Committee in clinical trials: FDA invites industry comment

Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees in ...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

Data monitoring committee OKs continuation of phase 3 trial for vidofludimus calcium

We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected]. An independent data monitoring committee has ruled that ...
JD Supra

FDA Issues Draft Guidance on Use of Data Monitoring Committees in Clinical Trials

A major shift in FDA’s current thinking, in comparison with the 2006 guidance, is heightened emphasis in the Agency’s view that DMC assessment of interim safety data alone is not sufficient. FDA ...
Nature

Data Monitoring Committees in Clinical Trials

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 investigators, ...
Nasdaq

SELLAS Life Sciences Announces Independent Data Monitoring Committee Periodic Review and Positive Recommendation to Continue Pivotal Phase 3 REGAL Trial of GPS in AML Without ...

NEW YORK, Aug. 07, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of ...
Business Wire

Sensorion Receives Positive Recommendation from Data Monitoring Committee of SENS-501’s Audiogene Phase 1/2 Clinical Trial

MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company specializing in the development of novel therapies to restore, ...
FiercePharma

Doctored data, protest from trial observers: Lawsuit points to alleged misconduct at Amgen-bought biotech

ChemoCentryx, the $3.7 billion biotech bought by Amgen in 2022, allegedly ignored repeated warnings from a data monitoring committee and withheld or manipulated trial results on the firm’s ...
The National Law Review

FDA Proposes Rule to Update Clinical Trial Data Monitoring

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
manilatimes

Actinogen receives positive Interim Analysis recommendation from its independent Data Monitoring Committee to continue the XanaMIA pivotal Alzheimer’s disease trial

XanaMIA trial fully enrolled with final results expected in November 2026 SYDNEY, Feb. 03, 2026 (GLOBE NEWSWIRE) -- Actinogen Medical Limited (ASX: ACW) announces that the XanaMIA pivotal Alzheimer’s ...
manilatimes

Independent Data Monitoring Committee Recommends Initiation of Cohort 2 at the Increased Dose of 12 mg/kg in Entrada Therapeutics’ ELEVATE-44-201 Study

-- Company on track to report ELEVATE-44-201 Cohort 1 data in Q2 2026, with Cohort 2 data by end of year -- BOSTON, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today ...