FDA would gain ability to easily change list of diseases eligible for incentive, avoiding need for one-off legislation or rulemaking.
After a significant update in 2014, some House members want to adjust the tropical disease priority review voucher program again in the 21st Century Cures bill to further increase its flexibility and popularity.
FDA would be required to create and publish a method for adding diseases to the list of those eligible for the voucher program as well as regularly update it, according...
The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on impact availability.
Webpages, a healthcare professional pamphlet and a medical conference exhibit booth panel make unsupported comparative superiority claims about generic torsemide products and misrepresent risks, the Office of Prescription Drug Promotion says in its first warning letter of 2025.
Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.
The Oncologic Drugs Advisory Committee voted 5-4 that the overall benefit-risk of UGN-102 is not favorable in patients with recurrent low grade, intermediate-risk, non-muscle invasive bladder cancer and also divided on whether randomized trials should be required for future development programs.
