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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Genentech, a Roche company, announced the U.S. Food and Drug Administration (FDA) had approved its Evrysdi (risdiplam) for spinal muscular atrophy (SMA) in adults and children two months of age and older.
In an aim to create a strong domestic supply chain, President Donald Trump signed an Executive Order on Thursday that calls for federal agencies to purchase “essential drugs” and medical supplies that are produced in the United States, rather than from abroad as is the current practice.
The FDA set a PDUFA target date of March 7, 2021 for aducanumab, Biogen said.
Although August is a busy month on the U.S. Food and Drug Administration (FDA)’s calendar for PDUFA dates, this week’s dates were almost all approved ahead of schedule. Here’s a look.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 7, 2020.
Eliquis generic was approved by FDA to prevent strokes, blood clots etc. But there were some legal issues which recently got stave off. Know more about it here.
Blenrep is GSK’s second regulatory approval in four months. GlaxoSmithKline is once again making its mark as an oncology-focused pharmaceutical company.
According to a warning from federal officials last week, dozens of drug companies, universities and medical device manufacturers owe more than a decade’s worth of data from clinical trials.
The U.S. government is seeking $11 billion in civil and criminal penalties from Purdue Pharma as the maker of OxyContin winds its way through bankruptcy.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 5, 2020.