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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
The U.S. FDA has accepted Genentech’s supplemental New Drug Application and has granted Priority Review for the company’s unclassifiable interstitial lung disease (UILD) treatment Esbriet® (pirfenidone).
Hours after being sworn in as the 46th President of the United States, Joe Biden signed 10 executive orders that are aimed at combating the ongoing COVID-19 crisis.
Rochelle Walensky, who most recently served as chief of the division of infectious diseases at Massachusetts General Hospital, will become the new head of the U.S. Centers for Disease Control and Prevention under the administration of Joe Biden.
The U.S. FDA has granted rare pediatric disease and orphan drug designations for Taysha Gene Therapies’ AAV9-based gene treatment candidate currently in development for epilepsy caused by SLC13A5 deficiency.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for January 19, 2021.
Daiichi Sankyo’s and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) has become the first HER2-directed medication approved to treat gastric cancer in the U.S. in 10 years.
Will there be enough doses of the two authorized mRNA COVID-19 vaccines to meet the lofty goal of 100 million inoculations within 100 days of the start of Joe Biden’s presidential administration?
The U.S. Food and Drug Administration approved Janssen Pharmaceuticals’ Darzalex Faspro for adults with newly diagnosed light chain amyloidosis.
After a start-of-the-year lull, activities at the U.S. Food and Drug Administration are starting to pick up. Here’s a look.
Although there are now two authorized vaccines against COVID-19 available in the United States and a third likely on the way with Johnson & Johnson’s candidate, the nation and world are nowhere near being done with the novel coronavirus, especially with new, more contagious variants now circulating.