Sanofi extended a license for its STAT6 program, while the FDA cleared an IND application for an IRAK4 degrader, and Gilead initiated a Phase 1 trial collaboration.

The entities involved

• Sanofi →

  company in Milan, Italy

  Nothing else this week.

• FDA →
  • Generic medicine services are seeking approval for launch from the FDA.Mon 17:49
  • A company is seeking FDA feedback on its NEO212 program, with a meeting scheduled at the FDA's White Oak campus.Mon 14:56
• Gilead Sciences →

  American company

  • Required regulatory filings regarding institutional holdings were made by Gilead Sciences, Inc. with the Securities and Exchange Commission on June 11, 2026.Sun 22:40
  • A pilot program is underway involving the federal government, Benue State, and Gilead Sciences, with the state participating in the drug supply management.Sat 01:51

Related events

• Gilead Sciences acquired Arcellx and presented priorities at a Wells Fargo conference, while also discussing submissions with the FDA and CDC.Sep 10
• GSK and EXEL are developing treatments for PBC, and the FDA granted accelerated approval to Gilead Sciences for related therapies.Jun 8
• NewcelX Ltd. advanced its IND-enabling work for a Phase 1/2a trial and held a successful Type B Pre-IND meeting with the FDA.Mon 14:50
• The FDA granted Safe to Proceed for the Pivotal Phase 3 study of Vivace Therapeutics, Inc.Aug 26
• A study protocol involving a company based in Mont-Saint-Guibert was approved by the U.S. FDA.Sep 2