The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency ...
The US Food and Drug Administration (FDA) has issued new guidance describing its current recommendations with respect to master protocols for the evaluation of drugs and biologics to treat or prevent ...
As compared to conventional, stand-alone clinical trials in advanced non-small cell lung cancer (NSCLC), the biomarker-driven Lung Cancer Master Protocol (Lung-MAP) has enrolled higher percentages of ...
Business as usual has not been the mantra for companies developing Covid-19 vaccines and drugs. Instead, biopharma companies and their partners pursued various transformational approaches to get ...
To accelerate drug development targeting the pandemic, the FDA issued final guidance May 17 on master protocols for drugs intended to prevent or treat COVID-19 infections. Although the guidance is ...
Biomarker-driven master protocols represent a new paradigm in oncology clinical trials, but their complex designs and wide-ranging genomic results returned can be difficult to communicate to ...
Financing extends Company’s cash runway beyond important clinical milestones anticipated beginning in 2H25, supporting the ongoing execution of the FORTE Master Protocol evaluating plixorafenib as a ...
Clonal Hematopoiesis as a Molecular Risk Factor for Doxorubicin-Induced Cardiotoxicity: A Proof-of-Concept Study Lung Cancer Master Protocol (Lung-MAP), a public-private partnership, established ...
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