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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The Oklahoma Supreme Court has overturned the landmark $465 million opioid verdict handed down against Johnson & Johnson in 2019.
Although Martin Shkreli continues to serve a prison sentence for fraud, the so-called “Pharma Bro” remains in legal hot water over antitrust charges.
Mid-November is a relatively quiet period for the U.S. Food and Drug Administration in terms of its scheduled PDUFA dates. Read on for more.
Ardelyx, Inc. is lacing up the gloves and preparing to wade into the ring with the U.S. Food and Drug Administration to dispute the July rejection of its chronic kidney disease drug, tenapanor.
The U.S. government canceled a contract with Maryland-based Emergent BioSolutions, which earlier in the year ruined about 15 million doses of the Johnson & Johnson COVID-19 vaccine.
Vaccinations will be required by January 4 under the new White House plan.
This agreement would cap out-of-pocket costs for insulin at $35 a month and all out-of-pocket medical costs for seniors at $2,000 a year.
Immunology expert Constance Cullen of Schering-Plough Corp. revealed that Theranos inappropriately attached Schering-Plough’s logo to data issued to potential investors.
The decision follows a 14-0 vote among members of an expert panel advising the agency.
The FDA informed Moderna that it would need more time to evaluate the company’s Emergency Use Authorization (EUA) submission for its COVID-19 vaccine for adolescents 12 to 17 years of age.