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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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 28, 2020.
The tests revealed that some metformin products contained the presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the regulatory agency.
Michael Bell, M.D., deputy director of the Division of Healthcare Quality Promotion at the Centers for Disease Control, teamed up with the Pandemic Action Network to help answer such questions and combat misinformation.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 27, 2020.
Bristol Myers Squibb is doing its best to claim market share in the checkpoint inhibitor space and over the past month, the company is pushing its way forward with a pair of regulatory approvals in lung cancer.
To date, Dupixent is the only biologic approved for this age group.
Alnylam Pharmaceuticals’ lumasiran for a chronic kidney stone disease was granted Priority Review status by the U.S. Food and Drug Administration. It will have a target action date of December 3, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 26, 2020.
Heading into the first week after Memorial Day, which in the U.S. marks the typical beginning of summer, the U.S. Food and Drug Administration has a number of drug approvals on the calendar. Here’s a look.
“Today’s approval of Kynmobi advances treatment options for people with Parkinson’s disease who experience OFF episodes and the associated disruption of everyday activities,” said Antony Loebel, Sunovion’s president and chief executive officer.