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
Padcev, which was approved by the U.S. Food and Drug Administration in December, secured Breakthrough Therapy designation for the treatment of patients with another type of bladder cancer.
To date, there are more than 72,000 confirmed and suspected cases of COVID-19 and 1,023 deaths from COVID-19, most in mainland China.
Hector Armando Kellum, a former senior executive with the Novartis subsidiary Sandoz, pleaded guilty for his role in a price-fixing scheme for generic drugs developed by his company.
Frank Reynolds, the founder and chief executive officer of PixarBio, was also ordered to repay $7.5 million to investors who backed the company’s non-opioid painkiller, NeuroRelease.
It doesn’t happen that often, but Merck’s checkpoint inhibitor Keytruda received a rejection from the U.S. Food and Drug Administration.
The U.S. Food and Drug Administration issued a statement on Friday outlining what the agency is doing at home and abroad in response to the outbreak, which has infected more than 73,000 people worldwide.
The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion is interested in how social media affects the public’s perception of drugs.
The U.S. Food and Drug Administration accepted the companies’ New Drug Application for lurbinectedin under Priority Review.
The U.S. Food and Drug Administration has a busy week planned for drug review. Here’s a look at this week’s schedule.
Now that global responses are fully mobilized, what is being done to identify and develop drugs and vaccines against this novel coronavirus?