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
An FDA advisory committee overwhelmingly votes in support of Sage’s post-partum depression drug, clearing the way for regulatory approval.
Two days after the FDA approved a powerful new sublingual opioid medication, FDA Commissioner Scott Gottlieb used his Twitter account to defend the approval amid concerns that the medication is susceptible to abuse.
Although there is some slowdown as the FDA moves into the holiday season in late November and into December, there are still upcoming target action dates. Here’s a look at this week’s PDUFA dates.
It was 36 years ago when Food and Drug Administration (FDA) approved Eli Lilly and Company’s Humulin, the first human Recombinant insulin for diabetes treatment.
MAPS is testing MDMA in a Phase III trial and hopes to seek regulatory approval by 2021.
Alkermes now faces a difficult uphill battle to gain regulatory approval for ALKS-5461 as a treatment for MDD.
The U.S. Food and Drug Administration issued a voluntary recall of a medication to treat high blood pressure due to trace amounts of a carcinogen being found within some lots of the drug.
The U.S. Food and Drug Administration (FDA) gave the green light to Hyrimoz, a biosimilar to AbbVie’s blockbuster drug Humira, five years ahead of the time it can be launched in U.S. markets.
The U.S. Food and Drug Administration (FDA) and Department of Homeland Security (DHS) are celebrating National Cybersecurity Awareness Month by announcing a strengthened partnership to buff up medical device cybersecurity, increasing communication and coordination between the two agencies.
Noting advances in genetic manipulation and gene editing, the Food and Drug Administration announced a new Plant and Animal Biotechnology Innovation Action Plan.