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Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees in ...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