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Feb 25, 2026
Novartis announced positive Phase III ALIGN results for Vanrafia in IgA nephropathy and plans to build a new radioligand therapy manufacturing site in Denton, Texas, operational by 2028.
Feb 24, 2026
Federal regulators unveiled a new regulatory approach to accelerate approval of personalized genetic treatments for rare, life-threatening conditions, allowing smaller studies when traditional large-scale trials aren't practical while maintaining post-market safety oversight.
Feb 19, 2026
The FDA will now require only one adequate and well-controlled clinical trial, combined with confirmatory evidence, to approve new drugs, ending its longtime two-study standard dating back to the 1960s.
Feb 18, 2026
The FDA agreed to review Moderna's mRNA flu vaccine after initially refusing the application, while separately announcing it will drop its longtime requirement for two clinical studies to approve new drugs.
Feb 16, 2026
Tozaro, a Bedfordshire-based biotech company, has raised £6 million in funding led by Mercia Ventures to advance its Smart Polymer technology aimed at reducing the high production costs of cell and gene therapies.
Feb 13, 2026
Sana Biotechnology received an analyst downgrade as the FDA increases regulatory scrutiny on gene therapies, raising questions about the company's cash runway and clinical progress ahead of its mid-March 2026 quarterly update.
