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The recommended dose of the drug for this age group is based on weight and liver function.
The FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic, released Wednesday, are “a really good first step in ensuring that clinical trials continue with minimum disruption,” according to Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP).
FDA
The U.S. Food and Drug Administration approved Abbott’s molecular test for the novel coronavirus that causes COVID-19 under an Emergency Use Authorization.
A summary of daily Biopharma industry news. Please check out stories that are trending on March 19, 2020.
Haselmeier officially announces that it has received Master File Number MAF3202 from the Food and Drug Administration of the United States for its D-Flex product platform, a new generation of injection pen systems for subcutaneous self-administration.
FDA
The U.S. Food and Drug Administration granted Eli Lilly and Company and Incyte Corporation Breakthrough Therapy designation for baricitinib for alopecia areata.
This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.
FDA
Hospitals and laboratories will be able to run the test on Roche’s fully automated cobas 6800 and cobas 8800 Systems, which are already in wide use in the U.S. and internationally.
Regenerative medicine promises to transform the way we see a number of chronic diseases, particularly cancer, and a number of research and development activities are currently underway to harness the possibilities with tissue engineering and molecular biology.
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