Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Gilead’s HCV Drug Sofosbuvir Picks Up Easy FDA Panel Endorsement

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...



A Rundown Of Real-Time Oncology Review Approvals And Pending Applications

Seattle Genetics holds the award for fastest supplemental approval (11 days) and fastest new molecular entity approval (119 days) under the US FDA's RTOR program, according to the Pink Sheet's Performance Tracker.

Taking The ‘O’ Out Of RTOR: US FDA’s Real-Time Review Primed For Expansion Beyond Oncology

Technology modernization efforts, the expansion of cloud-based submission capabilities, and the ongoing COVID-19 pandemic could serve as catalysts to broaden FDA’s Real-Time Oncology Review program beyond cancer therapeutics, Pfizer exec Richard Jahn says.

Rare Pediatric Disease Designation Requests Skyrocket Ahead Of Voucher Program’s Sunset

US FDA received 110 designation requests in July, a high mark that reflects the 60 days needed to review such requests ahead of the 30 September statutory expiration; agency is allowing email submission of RPD and orphan drug designation requests during the COVID-19 pandemic and expects to roll out an online portal for orphan designation requests later this year.

Topics

Related Companies

UsernamePublicRestriction

Register

MT142313

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel