New exploratory findings demonstrate that in responders with IGFBP7 biomarker decline, CNM-Au8 30mg was strongly associated ...
Concerns around the integrity of data from the RECORD4 trial of rivaroxaban (Xarelto; Bayer/Janssen), which were identified by the US Food and Drug Administration more than a decade ago, have been ...
NEW HAVEN, Conn., Oct. 25, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in ...
BioXcel Therapeutics faces regulatory challenges after the FDA found inconsistencies in one of its clinical trial sites, jeopardizing the supplementary approval of its drug, IGALMI. BioXcel's ...
FDA investigation into BioXcel's TRANQUILITY II study raises concerns about data integrity and management of the trial, impacting stock uncertainties. FDA's Type C meeting on November 8, 2023, will ...
Data integrity is an ongoing concern across all R&D organizations, no matter what part of the research lifecycle they’re navigating. These concerns extend beyond the potential for delayed timelines or ...
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