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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
GSK scored a pivotal Priority Review from the FDA for its RSV vaccine candidate for older adults, which will expedite regulatory evaluation of its clinical data.
Verge Genomics dosed its first patient in a Phase I trial studying VRG50635, while Stealth Bio’s SBT-272 was granted Orphan Drug designation by the FDA.
On Nov. 16, the FDA’s Cardiovascular and Renal Drug Advisory Committee will meet to discuss the relative merits of Ardelyx’s tenapanor in chronic kidney disease.
The implications of the Inflation Reduction Act of 2022 (IRA) are beginning to show as Alnylam drops the Stargardt indication for vutrisiran and Sanofi’s CEO reassures investors.
CytoDyn withdrew its pending Biologics License Application for leronlimab in HIV, citing concerns involving the contract research organization managing its trials.
The FDA has upheld the accelerated approval of Jazz Pharmaceuticals’ Zepzelca (lurbinectedin), even though the drug failed to reach its primary endpoint in the confirmatory Phase III ATLANTIS trial.
Minneapolis-based DiaMedica Therapeutics plans to conduct additional studies in order to resolve a clinical hold on its DM199 program for the treatment of acute ischemic stroke (AIS).
The FDA’s Oncologic Drugs Advisory Committee voted unanimously against approving l-omburtamab for children with a rare form of neuroblastoma, citing complex review issues.
One month after a contentious FDA advisory meeting, Oncopeptides announced positive data from the Phase III LIGHTHOUSE trial of Pepaxto in RRMM patients.
Ipsen hit another stumbling block in its bid for an FOP approval as the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee postponed its meeting on the NDA for palovarotene capsules.