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Genentech, Inc.

http://www.gene.com

Latest From Genentech, Inc.

Slow Down To Speed Up: US FDA Presses Cases For Dose Optimization

The US FDA is urging drug companies to abandon traditional approaches to oncology dosing even if it means slowing down early studies. The trade-off should be faster development times overall, FDA says – but sponsors still seem very wary.

Clinical Trials Regulation

Keeping Track: AZ’s Busy Oncology Biz, Phathom’s Voquezna Approval, And A Trio Of Complete Response Letters

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Approvals

User Fee Bill’s Accelerated Approval Reform Provisions Watered Down, But Could Speed Withdrawals

Withdrawal procedure in House consensus bill would require only one advisory committee hearing, instead of potentially two, likely shortening the time to a final decision.

User Fees Legislation

CEO Vounatsos, Aduhelm Commercial Team To Exit As Biogen Shifts Focus

The company will prioritize later-stage R&D, including potential accelerated approval for a second anti-amyloid antibody, while replacing its CEO and cutting Aduhelm commercial operations and other costs.

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Company Information

  • Industry
  • Pharmaceuticals
  • Biotechnology
    • Large Molecule
      • Antibodies
  • Other Names / Subsidiaries
    • Tanox
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