Regulatory
A summary of daily biopharma industry news. Please check out stories that are trending on March 23, 2020.
The U.S. Food and Drug Administration has a busy week of possible drug approvals on its calendar. Here’s a look.
A summary of daily Biopharma industry news. Please check out stories that are trending on March 20, 2020.
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).
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.
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.
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