Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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On Tuesday, the FDA extended its review of the Supplemental Biologics License Application for Arzerra in this indication by three months.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 3, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 2, 2020.
U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn recently gave a speech to the Alliance for a Stronger FDA. In it, he suggested that some of the changes forced on the agency by the COVID-19 pandemic are likely to become permanent.
AbbVie won first-of-its-kind approval for a non-surgical treatment, Oriahnn, aimed at treating heavy menstrual bleeding due to uterine fibroids, a common non-cancerous tumor, in pre-menopausal women.
Tecentriq is an anti-PD-L1 checkpoint inhibitor. Avastin binds to the VEGF protein, which plays a significant role in the development and maintenance of blood vessels by cancer cells.
Although the U.S. FDA is very busy dealing with emergency use approvals for diagnostics and possible treatments for COVID-19, it is still evaluating and approving therapies for non-COVID-19 indications. Here’s a look at this week’s calendar.
Tauvid is the first and only approved diagnostic agent for imaging tau neurofibrillary tangles (NFTs) in the brain.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 1, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 29, 2020.