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 Russian government is attempting to cast a negative light on the COVID-19 vaccine developed by Pfizer and BioNTech, as well as other vaccines, in order to boost sales of its own vaccine, Sputnik V, the government charged.
KemPharm announced this week that the U.S. Food and Drug Administration has approved its novel ADHD drug for use in patients six years and older.
Advocates from the ALS community flooded the FDA with letters, Tweets, emails, videos and other comments expressing their anger over the rejection and the frustration that there are few therapeutics for a disease that is a delayed death sentence.
GE Research selected DNA Script to join a collaboration working on a rapid response, mobile platform to develop on-demand production of nucleic acid-based vaccines and therapies related to biological threats.
Eye disease company Oyster Point announced the New Drug Application for its dry eye disease therapy OC-01, submitted in December, has been accepted for regulatory review on the back of positive Phase III data.
Cancer therapy company Athenex suffered a regulatory setback with the receipt of a complete response letter from the U.S. Food and Drug Administration.
The U.S. FDA has decided to put together an advisory committee meeting of outside experts to review a New Drug Application for roxadustat, FibroGen and its partner AstraZeneca’s investigational anemia therapy.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 2, 2021.
The company notes that this decision has no effect on other indications for Keytruda.
This approval marks the first treatment indicated for reducing mortality risk in patients with the rare disorder known as molybdenum cofactor deficiency (MoCD) Type A.