Gilead’s HCV Drug Sofosbuvir Picks Up Easy FDA Panel Endorsement
This article was originally published in The Pink Sheet Daily
Executive Summary
Antiviral Drugs Advisory Committee unanimously recommends approval in HCV genotypes 1-4 and supports use in a subgroup of patients awaiting liver transplant, but says more data are needed in transplant patients with more severe disease.
You may also be interested in...
Upcoming COVID Vaccines Cmte. May Be More For Public Education Than Advising US FDA
Agenda for Thursday’s meeting on coronavirus vaccine development and approval includes lots of background, which may help public confidence, but not necessarily FDA assessors as they weigh the tough decisions ahead of them.
US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios
Forthcoming guidance is expected to describe areas of “low-hanging fruit” and those that are more challenging for use of the expedited pathway, Center for Biologics Evaluation and Research Director Peter Marks said.
Puberty Blockers: FDA's Califf Asked If REMS, Boxed Warning Against Off-Label Use In The Works
FDA Commissioner Robert Califf tells House appropriations subcommittee chair the agency will 'consider any information that may be available' on off-label use of puberty blockers for gender dysphoria before making a regulatory decision.