FDA announces CMC review pilot for drugs with expedited development The US Food and Drug Administration (FDA) announced on 31 October a limited chemistry, manufacturing and controls (CMC) development ...
Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological malignancies, today announced that the U.S. Food and Drug ...
iECURE, Inc., a clinical-stage genome editing company developing variant-agnostic in vivo targeted gene insertion therapies for the treatment of severe, inherited, neurometabolic disorders, today ...
WASHINGTON – Denise Gavin, the director of the Office of Gene Therapy at the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), emphasized that clinical ...
Breakthrough Therapy designation based on interim clinical data from Phase I/II trials showing clinically meaningful improvements in cardiac biomarkers and functional measures LX2006 also selected for ...
The market opportunity lies in offering specialized training and consultancy services to pharmaceutical companies for navigating complex CMC regulatory requirements for biological drugs, ensuring ...
Clinical efficacy top-line results of PARADIGM, a Phase 2b trial in ALS, expected in December 2023 CAMBRIDGE, Mass., Nov. 13, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NRSN) ("NeuroSense"), a ...
Wugen Selected for U.S. FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program to Support Manufacturing Readiness of Soficabtagene Geleucel -- FDA Chemistry, Manufacturing, ...
Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological malignancies, today announced that the U.S. Food and Drug ...
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