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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Wednesday evening, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 7-2 to recommend approval of Amylyx ALS candidate AMX0035.
Thousands of FDA employees may lose their jobs if Congress doesn’t reappropriate funding currently in place by the end of the month.
The FDA removed the clinical hold on Sarepta’s investigational treatment for certain types of DMD after the company agreed to adjust its clinical trial protocols.
Industry observers say the Inflation Reduction Act of 2022 could affect the direction of research, and some fear it may lead to further government forays into price control.
The FDA provided briefing documents ahead of Amylyx’s rare second adcomm for AMX0035, an investigational treatment for ALS. The regulator does not appear to be convinced.
The U.S. Food and Drug Administration had a busy week leading up to the Labor Day holiday. Here’s a look at the agency’s recent activities.
The Administrative Law Judge overseeing the FTC’s challenge of Illumina’s acquisition of Grail rejected the regulator’s anti-competition argument, Illumina announced Thursday.
A High Court judge in London granted AstraZeneca an injunction, temporarily blocking a former executive from joining rival pharma GSK.
The problem of intellectual property theft is greater than most biopharma executives realize, but the real issue is that companies are protecting only a fraction of their IP.
The University of Michigan and the University of South Florida have filed a lawsuit against Novartis, alleging the company’s cardiac drug, Entresto, infringes a cocrystal patent held by both universities.