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 lawsuit filed by the Pharmaceutical Research and Manufacturers of America failed to block an Arkansas law that empowers hospitals to use outside pharmacies to dispense discounted drugs.
In a change of position as congressional scrutiny of WuXi AppTec grows, the Biotechnology Innovation Organization announced it is taking steps to separate from the China-based biotech.
With an advisory committee meeting slated for Friday, the regulator has posted briefing documents in which it has raised concerns about early deaths in patients treated with Bristol Myers Squibb’s Abecma and Johnson & Johnson’s Carvykti.
The FDA will close out a hectic month of March with a flurry of target action dates, including ones for lymphoma and CKD anemia treatments.
Heather, Greg and Tyler discuss a busy news week including Wegovy’s label expansion, biosimilars, surprise donanemab delays for Eli Lilly and speculate on election impact.
In a briefing document for Thursday’s advisory committee meeting, the FDA pointed to efficacy and safety issues with Geron’s New Drug Application for imetelstat in myelodysplastic syndromes.
A controversial decision by the Alabama Supreme Court temporarily chilled IVF before igniting nationwide pushes to protect access to this type of fertility treatment, leaving drugmakers with questions.
The FDA plans to convene an advisory committee meeting to discuss the safety profile and efficacy of Eli Lilly’s Alzheimer’s candidate, the company announced Friday.
The regulator’s new draft guidance, released on Monday, provides additional details regarding the use of surrogate and biomarker endpoints to support accelerated approvals.
Acadia Pharmaceuticals is terminating development of its antipsychotic drug pimavanserin, which did not demonstrate a statistically significant improvement over placebo in the late-stage study’s primary endpoint.