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 two were charged with conspiracy to commit trade secret theft and wire fraud, international money laundering and obstruction of justice.
Following a manufacturing mistake that left Emergent BioSolutions with a botched batch of Johnson & Johnson’s COVID-19 vaccine, Emergent is now facing a shareholder lawsuit accusing the company of insider trading.
The WHO is calling for manufacturers to cut prices and increase the availability of supplies to low- and middle-income nations to parts of the world where COVID-19 continues to surge.
bluebird bio is hitting back at Spark Therapeutics over the use of the word “spark” involving the company’s “Be the Spark” campaign against sickle cell disease.
Continuing studies and news about COVID-19 around the world keeps coming in. Here’s a look.
The board strongly believes that Walmsley is the correct leader for the pharmaceutical business arm of GSK, which is being referred to as New GSK.
After the July 4 holiday, the U.S. FDA has several things on their immediate calendar, including a couple target action dates and an advisory committee hearing. Here’s a look.
It’s a busy news day for COVID-19-related stories. Read on for more.
On Monday, the House passed a bipartisan bill designed to reportedly boost scientific research and increase the scientific competitiveness of the U.S. to that of China.
The deal was originally inked in 2005, where U.S.-based Chiron Corp. made payments to Genentech, a Roche company.