Policy
Nader Pourhassan, who led CytoDyn for nearly 10 years, was convicted in December 2024 of misleading investors regarding the biotech’s investigational COVID-19 and HIV drug, which artificially inflated its share price.
FEATURED STORIES
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Former European Trade Commissioner Phil Hogan and former U.S. Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
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Days after Novartis axed one-fifth of its research programs, the Swiss pharma giant said it intends to seek regulatory approval for 60 new treatments between 2019 and 2021.
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.