FDA cleared the IND application for a clinical trial of the StealthX™ vaccine, funded by NIAID and conducted in collaboration with NIH and HHS.

The entities involved

• 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
• Capricor Therapeutics (United States) →

  company in Beverly Hills, United States

  Nothing else this week.

• National Institutes of Health →

  government organization in Shah Alam, Malaysia

  • PDS Biotechnology and the National Cancer Institute entered into a collaborative R&D agreement.Sun 13:48
  • The Trump administration seeks greater control over NIH grantmaking, while Susan Collins objects to the Office of Management and Budget's involvement.Sat 04:05

Related events

• A clinical study led by Dr. Swee Lay Thein is underway at the National Institutes of Health and is subject to oversight by the Food and Drug Administration.Aug 19
• A supply deal for NUBEQA was finalized between ORIC Pharmaceuticals and BAYER after talks with the FDA.Sep 15
• On August 28, 2026, the FDA approved Moderna's mNEXSPIKE vaccine and gave the green light to Novavax's Nuvaxovid vaccine. Separately, ProFound Therapeutics was formed by Flagship Pioneering.Aug 28
• FDA granted approval for Pfizer's updated vaccine on September 2, 2025.Jun 7
• Capricor Therapeutics is seeking regulatory approval from the FDA for clinical trials and has listed on the Nasdaq stock exchange, with a law firm based in New York City involved.Aug 5