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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A major factor behind the success of the smallpox eradication campaign was political commitment and leadership.
The U.S. Food and Drug Administration is wrapping up 2021 with a fairly busy schedule for the month of December. Here’s a look at the first half of the month.
Two years into the COVID-19 pandemic, countries are reporting the fourth wave of rising cases, driven mainly by the Delta variant, although Omicron has everybody concerned. Here’s a look.
The SEC announced charges against Usama Malik and his former live-in girlfriend Lauren S. Wood regarding an FDA decision during a trading black out.
Four BMS employees have filed a lawsuit against BMS after claiming the company would not grant them a religious exemption and threatened their employment.
In the CRL, the FDA indicated that the single registrational trial (106 Phase III) did not provide sufficient proof of efficacy to demonstrate benefit.
In open court, the prosecution examined hundreds of text messages sent between Holmes and Balwani, honing in on the romantic exchange between the two.
The FDA’s Antimicrobial Drugs Advisory Committee voted 13 to 10 to recommend emergency authorization of molnupiravir. Read more about the authorization here.
Elizabeth Holmes blames the allegations of investor fraud perpetrated by her blood-testing company Theranos at the feet of her former business partner Ramesh “Sunny” Balwani.
The CDC has shifted its recommendation on adults getting a booster COVID-19 vaccine to now include everyone ages 18 years and older.