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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Please check out the biopharma industry’s COVID-19 stories that are trending for May 11, 2021.
May is a busy month for the U.S. Food and Drug Administration (FDA)’s calendar for new drug reviews. Here’s a look.
On Thursday, Pfizer Chief Executive Officer Albert Bourla who is “not at all” in favor of the U.S. position, stated that the real challenge is manufacturing capacity.
While the U.S. had been one of a few rich nations holding out – along with Canada, the European Union and Britain – on some level, Wednesday’s announcement of support for the proposal is not unexpected.
The U.S. FDA approved Keytruda combined with Genentech’s Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
Theranos founder Elizabeth Holmes is back in the courtroom for the first time in 15 months for a three-day hearing ahead of her criminal fraud trial.
Here’s a look at Pfizer-BioNTech, Novavax and the COVID-19 vaccine’s sales, approval in children, additional trials, potential of booster shots, and more.
The U.S. FDA cites concerns regarding clinical data for ChemoCentryx’s investigational rare autoimmune disease therapy avacopan. Shares in the company plunged 46.5% lower following the release of the document.
Pfizer reported its first-quarter 2021 revenues of $14.6 billion, an impressive 42% operational growth.
Please check out the biopharma industry’s COVID-19 stories that are trending for May 4, 2021.