Topic: FDA application process
The agency said it has begun implementing three recommendations from HHS to fully integrate cybersecurity requirements into its premarket reviews.
The FDA has rejected Vernalis’ filing for approval of CCP-08, scuttling its hopes of coming to market in time for the 2017-18 cough-cold season.
Officials knocked back the filing after phase 3 data linked the sclerostin-targeting antibody to an increased risk of cardiovascular adverse events.
Shares in Puma Biotechnology jumped 40% after the FDA trod lightly around doubts about its filing for approval of breast cancer drug neratinib.
As expected, an FDA panel voted in favor of giving Dexcom’s G5 continuous glucose monitor a nonadjunctive indication that would allow it to be used in place of standard daily finger-stick blood testing.
The FDA appears to be leaning toward a favorable outcome for Dexcom’s PMA for its G5 continuous glucose monitor, which is scheduled for review by a regulatory agency panel this Thursday.
The FDA today raised a host of thorny issues for an upcoming advisory committee meeting scheduled to review Clovis Oncology's application for an accelerated approval of its non-small cell lung cancer drug rociletinib.