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 will meet Friday to discuss the future of Secura Bio’s Copiktra (duvelisib), which has been approved as a third-line treatment for relapsed or refractory CLL/SLL.
Merck announced positive results on its patent infringement case against Viatris, while Amgen faces political headwinds from the White House.
The U.S. FDA had a busy week with a range of drug approvals, advisory committee meetings and classification announcements.
A 3-judge panel questioned the legitimacy of Johnson & Johnson’s plan to form a subsidiary company with the purpose of absorbing legal liabilities from talc-related lawsuits.
The FDA granted rare pediatric disease designation to AVR-RD-04, an experimental gene therapy treatment for the lysosomal storage disease cystinosis, AVROBIO announced Tuesday.
Shares of Spectrum Pharmaceuticals plunged 33% upon the release of briefing documents for an FDA advisory meeting regarding poziotinib
Pres. Joe Biden declared the COVID-19 pandemic over. Biopharma stocks react as vaccines and antivirals are still in development.
The FDA has a broad range of activities in the drug and medical device space. Here’s a look at the agency’s work this week.
The FDA has two PDUFA dates on its calendar this week, with two extra days slotted for an advisory committee meeting to evaluate drug applications from three companies.
The Lancet Commission published a lengthy criticism of the WHO’s COVID-19 pandemic response. In turn, the WHO offered a reply to a number of the complaints.