Food and Drug Administration (FDA)
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The approval marks the first for EoE, a chronic, progressive type 2 inflammatory disease that damages the eosinophilic esophagitis and prevents it from working properly.
The hold follows a serious adverse event in which a study participant died after developing possible differentiation syndrome.
Bayer has terminated a two year-old partnership with Atara to develop off-the-shelf T-cell immunotherapy for high mesothelin-expressing tumors.
Pfizer with Headlands Research plans to launch new clinical trial sites in areas that have highly diverse populations.
The FDA has a few target action dates for the end of the month, although PDUFA dates can sometimes seem like a moving target.
Zealand Pharma shared positive top-line results for its second Phase III clinical trial of its congenital hyperinsulinism (CHI) drug, dasiglucagon, in pediatric patients.
On Thursday, Mersana announced that the FDA granted an orphan drug designation to one of its lead assets, XMT-2056, which is intended to treat gastric cancer.
U.K. researchers found that the first dose of any vaccine was linked with an initial 12.8% decrease in the odds of Long COVID.
Applied Molecular Transport (AMT) provided a strategy update on Wednesday. Part of the update includes reducing its workforce by about 40% and funneling resources into its lead program.
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