Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Gilead Sciences, Inc.

http://www.gilead.com

Latest From Gilead Sciences, Inc.

China Approves Two More Home-Grown COVID-19 Antivirals

Top-line results for two newly approved COVID-19 antivirals in China showed roughly 1.5- to two-day cuts in median time to symptom resolution or recovery in mild-to-moderate Omicron patients versus placebo.

China Approvals

End Of US FDA’s Very Fast Reviews? 2022 Novel Approvals Stayed Close To PDUFA Timeframes

Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months. A Pink Sheet infographic breaks down which review pathways did the best last year. 

Pink Sheet Perspectives US FDA Performance Tracker

As COVID Public Health Emergency Winds Down, US FDA Employs Flexibility For Rx EUA Transitions

Biden administration sets May 11 as end date for public health emergency. CDER has said it will work with sponsors to help them gain approval of COVID therapeutics cleared under emergency use authorizations, but agency will likely not issue a formal transition framework.

Pink Sheet Perspectives Coronavirus COVID-19

CAR-Ts May Be Closer Competitors To Lilly’s Jaypirca Than Fellow BTK Inhibitors

The Loxo@Lilly drug got FDA accelerated approval in mantle cell lymphoma as the first non-covalent BTK inhibitor, enabling its use in post-BTKi disease.

Approvals Business Strategies
See All

Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
    • Drug Delivery
    • Specialty Pharmaceuticals
  • Other Names / Subsidiaries
    • Arresto Biosciences, Inc.
    • Asegua Therapeutics, LLC
    • Calistoga Pharmaceuticals, Inc.
    • CGI Pharmaceuticals, Inc.
    • CV Therapeutics, Inc.
    • Cytopia Limited
    • EpiTherapeutics
    • Eximias Pharmaceutical Corporation
    • Immunomedics, Inc.
    • MiroBio
    • Myogen
    • MYR GmbH
    • Nimbus Apollo, Inc.
    • Nexstar Pharmaceuticals
    • Oligogen, Inc.
    • Pharmasset, Inc.
    • Triangle Pharmaceuticals
    • YM BioSciences Inc. (YMI)
    • Kite Pharma, Inc.
    • Kite Pharma EU
    • T-Cell Factory B.V. (TCF)
    • Cell Design Labs, Inc.
    • Asegua Therapeutics
UsernamePublicRestriction

Register