Fierce Pharma

Ipsen backs away from cancer med Tazverik after safety signals emerge in lymphoma trial

Ipsen telegraphed plans to acquire Epizyme and the FDA-approved Tazverik in June 2022, two years after the med’s clearance in the U.S. as both an epithelioid sarcoma and follicular lymphoma treatment.
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Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees in ...
Business Insider

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

SYDNEY, Feb. 03, 2026 (GLOBE NEWSWIRE) -- Actinogen Medical Limited (ASX: ACW) announces that the XanaMIA pivotal Alzheimer’s disease (AD) trial’s independent Data Monitoring Committee (DMC) has ...
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, ...
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FDA Issues Draft Guidance on Use of Data Monitoring Committees in Clinical Trials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 ...
Nasdaq

SELLAS Life Sciences Announces Positive Recommendation from the Independent Data Monitoring Committee of the Phase 3 REGAL Trial in Acute Myeloid Leukemia

NEW YORK, June 17, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of ...
Seeking Alpha

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. (SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel ...
Nasdaq

Alterity Therapeutics Phase 2 Data Monitoring Committee Recommends Continuing Clinical Trial as Planned After Second Review

MELBOURNE, AUSTRALIA AND SAN FRANCISCO, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing ...
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, ...
Business Insider

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

-- Patients in Cohort 1 have progressed to the open label, Phase 2 portion of ELEVATE-44-201 -- -- Company on track to report ELEVATE-44-201 Cohort 1 data in Q2 2026, with Cohort 2 data by end of year ...