The FDA approved various advanced therapies, including oral medication from Roche, a gene-targeting drug from Biogen, and a one-time gene therapy from Novartis.

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
• Hoffmann-La Roche →

  Swiss healthcare company

  • Natera's Signatera test is undergoing a Phase III trial across US sites, sponsored by NRG Oncology, while facing patent litigation.Sun 02:44
  • Hoffmann-La Roche opened a new R&D center in Boston.Sat 11:08
• Biogen →

  American multinational biotechnology company

  Nothing else this week.

• Novartis →

  Swiss-American multinational pharmaceutical corporation

  • Novartis acquired Avidity in a $12 billion purchase, while Trump simultaneously threatened Swiss businesses with tariffs.Sat 01:46
  • GSK and Novartis are identified as major pharmaceutical companies.Fri 02:16

Related events

• FDA placed a clinical hold on a gene therapy involving Hunter.Aug 25
• Solid Biosciences received FDA approval for a gene therapy trial on July 9, 2025.Jun 8
• The FDA reviewed gene therapy applications and provided milestone payments for dosing involving Regenxbio and AbbVie.Aug 6
• Novartis sought Swissmedic regulatory approval for a drug, which was co-funded by Sida and introduced first in Ghana.Sep 15
• Experimental therapies require approval from the FDA.Sep 21