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 FDA’s Oncologic Drugs Advisory Committee will meet March 9 to discuss Roche’s sBLA for Polivy in first-line DLBCL, while Acadia awaits potential approval of the first therapy for Rett Syndrome.
Sen. Bernie Sanders (I-VT), chairman of the Senate’s Health, Education, Labor and Pensions Committee, sent a letter to Sanofi and Novo Nordisk urging them to lower insulin prices.
In 2022, Elon Musk’s Neuralink tried – and failed – to secure permission from the FDA to run a human trial of its implantable brain-computer interface, according to a report published Thursday.
Citing lack of efficacy evidence, the FDA rejected Cytokinetics’ heart failure hopeful omecamtiv mecarbil in a decision announced Tuesday evening.
Billy Dunn, director of the FDA’s Office of Neuroscience, is stepping down from his post to “explore other opportunities,” according to an internal FDA e-mail.
Senate Bill 1162, a law requiring employers to include pay ranges in all job advertisements, went into effect in California January 1. Here’s how employers are responding.
The 2024 presidential candidate sat down with BioSpace in an exclusive interview to outline the key points of his campaign - including his thoughts on the FDA.
The FDA is expected to cap off February with a trio of verdicts, including one for a heart failure treatment and another potential first approval for a rare, neurodegenerative disease.
The FDA accepted the BLA for and granted Pfizer’s maternal RSV vaccine candidate priority review.
Akebia Therapeutics announced another delay Tuesday in a series of setbacks for vadadustat, being developed to treat anemia linked to chronic kidney disease.