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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Wrapping up June and ahead of the July 4 holiday, the U.S. Food and Drug Administration (FDA) has a busy two-week period coming up for drug approvals. Here’s a look.
Crysvita is a drug developed by Ultragenyx Pharmaceutical and Tokyo-based Kyowa Kirin Co. Ltd., a specialty pharmaceutical company.
The FDA approved a supplemental New Drug Application for Tazverik (tazemetostat) for the treatment of two distinct follicular lymphoma (FL) indications.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 19, 2020.
The U.S. Court of Appeals upheld a ruling that the Trump administration does not have the legal authority to mandate that drug companies disclose the list price of medications in television advertisements.
This is the second such biomarker-specific approval for Keytruda. The first biomarker-specific approval came in 2017.
Novartis is the first company to the finish line with an approved treatment for Adult-Onset Still’s Disease (AOSD), a rare autoinflammatory disease of unknown origin.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 17, 2020.
The game was reviewed through the agency’s de novo pathway and as a result, creates a new class of digital therapeutics.
The warning came only a few hours after the FDA rescinded Emergency Use Authorization (EUA) for hydroxychloroquine and chloroquine for the treatment of COVID-19.