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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Positive Opinion is based on data from the Phase 3 TITAN study which were published in The New England Journal of Medicine
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PERTH, AU, Dec 13, 2019 - - Holista CollTech announced that it has filed its 100%-owned global patent for platform technology that will deliver many fat-soluble medications by creating a water-soluble delivery system.
Dublin-based Avadel Pharma announced that the U.S. Food and Drug Administration had approved its Nouress for neonatal patients requiring total parenteral nutrition.
The plan, put forth by House Speaker Nancy Pelosi, was passed last week on a mostly party-line vote, with support from two Republicans.
BMS accused Kite and Gilead of copying the research conducted at Memorial Sloan Kettering to push the development of Yescarta.
The FDA approved extended-release 11 mg and 22 mg tablets as a once-daily treatment from the chronic inflammatory condition.
The U.S. Food and Drug Administration is wrapping up 2019 with a few PDUFA dates. Here’s a look.
The U.S. Senate confirmed Hahn as the new commissioner Thursday in a 72-18 vote.
House Speaker Nancy Pelosi’s drug pricing reform bill passed the House of Representatives in a mostly party-line vote and will now head to the U.S. Senate, where its chances of moving forward in the Republican-led chamber are slim.