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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 is still fending off patent challenges over the lipid nanoparticle delivery system used in its COVID-19 vaccine.
Today’s announcement from Seagen’s board of directors included difficult news regarding Clay Siegall, Ph.D. Until today, Siegall served as Seagen’s President, CEO and Chairman.
The U.S. SEC continues to tighten the screws on Chinese companies, adding more than 80 companies to its expanding list of companies that might be dropped from U.S. stock exchanges.
Despite having infinitely better global communications, exact figures are hard to come by for COVID-19 fatalities. Here’s a look at that story and more COVID-19 news.
Despite a growing product revenue, Beigene reported a net loss of $434.4 million for the first quarter of 2022, as well as updates to its audit from the SEC.
A post hoc analysis of data from the Phase II CENTAUR study showed a 10.6-month longer median survival duration for AMX0035 participants, Amylyx announced Thursday.
The FDA’s reaction came after Pfizer CEO Albert Bourla said that physicians may give a second five-day course of Paxlovid if patients see a spike in their SARS-CoV-2 viral load.
New studies suggest that the virus may aggravate childhood asthma after infection. For that and more COVID-19 news, continue reading.
The WHO issued an alarming statement that details a 79% increase in child measles outbreaks globally, as well as a warning that 11 countries have reported peculiar acute cases of hepatitis in children.
Three long-time FDA officials, Dr. Peter Marks, Dr. Janet Woodcock and Dr. Robert Califf wrote an op-ed in JAMA describing the reality that COVID-19 represents “the new normal.”