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The Phase II study showed that the asset achieved antiviral activity in healthy patients and set the stage for AT-527’s potential as a preventative treatment for COVID following exposure to the virus.
Palovarotene is being developed for the prevention of heterotropic ossification, which is new bone formation in people with fibrodysplasia ossificans progressive.
The amended EUA is aimed at patients who have undergone solid organ transplants or those diagnosed with conditions that have an “equivalent level of immunocompromised.”
This approval was based on the Phase III withdrawal study that showed clinically meaningful differences vs. placebo in change to the primary endpoint, Epworth Sleepiness Scale score.
Aprea’s clinical trial is evaluating a combination of eprenetapopt with acalabrutinib or with venetoclax and rituximab.
Republican Senator Rand Paul is under fire from government watchdogs for failing to properly disclose a $15,000 purchase of Gilead Sciences stock made by his wife last year.
The U.S. FDA greenlit the combination of Keytruda and Eisai’s Lemvima as a first-line treatment for adult patients with advanced renal cell carcinoma.
Citing a study from Johns Hopkins University, researchers found that immunocompromised people are 485 times more likely to end up in the hospital or die from COVID-19.
The FDA indicated the drug couldn’t be approved in its present form and asked for another clinical trial of the drug be run before they reapplied.
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