The rare disease framework has had a turbulent past few years, with the FDA looking to create regulatory stability.
Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), ...
In a fit of boundless national optimism, Peugeot and Renault (and a few years later Volvo) teamed up to make a new V8 for good power and performance. But that's not what the world got. We welcomed in ...
With the rare pediatric disease and medical countermeasure priority review voucher (PRV) programs set to expire by 2022 and 2023, respectively, the Government Accountability Office (GAO) released a ...
ZYCUBO® approved by FDA to treat Menkes disease in the United States; Fortress subsidiary Cyprium Therapeutics sold its Rare ...
While the price of just about everything has increased over the last six years in the U.S., the same can’t be said for the cost of an FDA priority review voucher. Just ask Sarepta Therapeutics. Since ...
PRV RENAMED: What's in a name? Apparently something, at least in the view of the U.S. Air Force, which says it is changing the name of the Personnel Recovery Vehicle (PRV) program to Combat Search and ...
The Senate Health, Education, Labor & Pensions committee on Wednesday advanced seven bills, including one that would reauthorize the rare pediatric priority review voucher (PRV) program through 2022, ...