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 uses special designations to get new, breakthrough treatments to patients in the greatest need.
As the year winds down, the top companies in the COVID-19 vaccine race are nearing the finish line in the United States and other countries around the world.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 1, 2020.
The FDA approval was based on results from the largest studies conducted to date in obesity associated with POMC, PCSK1 or LEPR deficiency.
Moderna announced that it plans to submit its request to the U.S. Food and Drug Administration for an Emergency Use Authorization for its COVID-19 vaccine, mRNA-1273.
Guardant Health is taking Roche-owned Foundation Medicine to court over a patent dispute for their liquid biopsy technology, further heating up the rivalry between the two cancer detection companies.
The interim final rule aligns payment for Medicare Part B therapeutics with international prices and removes incentives for physicians to prescribe more expensive drugs and biologics.
The end of November and beginning of December is marked by several PDUFA dates at the U.S. Food and Drug Administration (FDA). Here’s a look.
Days after Purdue Pharma reached a combined $8.4 billion criminal and civil settlement with the U.S. Department of Justice, the OxyContin drugmaker pleaded guilty to three criminal charges to resolve its role in the ongoing opioid crisis in the United States.
Genentech’s influenza treatment Xofluza® (baloxavir marboxil) has been granted approval by the U.S. Food and Drug Administration for use in people 12 years and older, making it the first single-dose post-exposure prophylaxis strategy approved by the agency.