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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Moderna continues to assess its COVID-19 vaccine in juveniles, the company is expanding the study to include protocols to detect the potential of rare side effects, including heart inflammation.
Bristol Myers Squibb (BMS) announced Friday its decision to withdraw from the U.S. market the indication for its immune checkpoint inhibitor Opdivo® (nivolumab) as monotherapy for hepatocellular carcinoma (HCC) in patients previously treated with sorafenib.
A recent report suggests that cross-contamination is not all that uncommon of an issue, and maybe inevitable.
In a filing with the U.S. Securities and Exchange Commission earlier this month, Rosenbaum and his investment group nominated five directors to elect the CytoDyn board.
A vaccine for herpes is under development and Rational Vaccines are going to make this a reality very soon. Here’s everything you need to learn about it.
Novartis claimed the patents held by Plexxikon were invalid. Unfortunately for the company, the jury found it was unable to prove these claims.
As COVID-19 begins yet another surge across the U.S., there is some promising news about the effectiveness of vaccines. Here’s a look at some top COVID-19 stories.
Total payment amounts are contingent on the number of governments that will agree to suspend their lawsuits as part of the deal.
WHO Investigators have attempted to return to the Wuhan lab to find the origins of the novel coronavirus but are now being blocked by the Chinese government.
The U.S. Food and Drug Administration has recently granted Breakthrough Device Designation to two medical device companies, with California-based healthcare tech company Endologix leading the mix.