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Gilead Sciences, Inc.

http://www.gilead.com

Latest From Gilead Sciences, Inc.

Muted Q2 But Biocon Confident Of Insulin Glargine’s Onward US March

Biocon Biologics upbeat on Lantus follow-on’s long revenue stream and prospects for interchangeability, while operational challenges resulted in some supply constraints during the fiscal second quarter.

Commercial Biosimilars

Speedy Approval Of Gilead’s Veklury Sets Stage For Pediatric Expansion, Dosing Refinement

US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.

Post Market Regulation & Studies Approvals

US FDA Gives Wholesalers But Not Manufacturers More Time To Begin Verifying Saleable Returns

Wholesalers are given three more years to set up electronic systems to verify saleable returns under another reprieve from the FDA. Yet the reprieve does not extend to manufacturers, who must respond within 24 hours to wholesalers’ requests to manually verify that a returned product is not suspect.

Manufacturing Quality

Coronavirus Update: Gilead's Veklury Gets Full FDA Approval, Roche Partners With Atea

Gilead's remdesivir is first drug fully approved by FDA to treat COVID-19. Roche and Atea team up on an investigational direct acting antiviral while Moderna reaches the 30,000-patient enrollment target for its Phase III COVE study of the company's investigational mRNA vaccine. 

Coronavirus COVID-19 Vaccines
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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.
    • Myogen
    • 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
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