FDA's Expedited IND Comment Window Nears Close After Gene Therapy Holds
FDA's comment window on the Expedited IND pilot closes July 22, 2026, after clinical holds hit REGENXBIO and Intellia gene therapy programs.
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Page 7 of 7 · Updated 7 Oct 2026, 18:23 UTC
FDA's comment window on the Expedited IND pilot closes July 22, 2026, after clinical holds hit REGENXBIO and Intellia gene therapy programs.
Epoch AI's EBR-bench, announced July 8, 2026, uses the board game Earthborne Rangers to test whether AI models improve with practice. So far, they don't.
FDA granted interchangeability designation to Celltrion and Teva's Truxima on July 1, 2026, the first rituximab biosimilar to achieve the status.
The EDPB adopted guidelines on web scraping for generative AI and opened consultation until October 30, 2026 — what changes for AI companies.
The completed deal adds gamgertamig, a BCMAxCD3 T-cell engager with FDA Fast Track and Orphan Drug designations, to Gilead's inflammation pipeline.
Fox agreed on June 15, 2026 to acquire Roku at $160 per share, roughly $22 billion enterprise value, with closing expected in the first half of 2027.
Parabilis Medicines priced a $670 million IPO on June 9, 2026, the largest ever for a venture-backed biotech, extending 2026's streak of large listings.
Siri AI, previewed June 8, 2026 at WWDC26, adds on-screen awareness and web answers, with a staged rollout and disclosed limits.
FDA accepted Vertex's povetacicept BLA for accelerated approval in IgA nephropathy with a November 30, 2026 PDUFA date, on 52% UPCR reduction data.
Apple's June 8, 2026 WWDC announcement covers iOS 27, a rebuilt Siri AI, faster performance claims, and new parental controls.
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