Coming soon

Ask REGTEKA AI is on its way.

Ask regulatory questions across REGTEKA intelligence.

Hear when it launches: the Regulatory Briefing

Industry

Advanced Therapies

Cell and gene therapies, oncolytic viruses included: approvals, advisory committees, review extensions and sponsor guidance.

20 stories

Regulatory News has published 20 Advanced Therapies stories between 17 July 2026 and 31 October 2026, each sourced to the primary record — the Federal Register entry, the Official Journal notice, the guidance document or the regulator’s own release — and written and edited by Connor Griggs, the publication’s editor. Last updated 31 October 2026.

All coverage

20 stories, newest first.

Search within Advanced Therapies coverage, or narrow it further.

Sections Agencies Series

Showing 20 of 20 stories

A clinician ties a blue surgical gown in a clinical setting, a generic pre-procedure stand-in For Physicians MHRA Lowers Casgevy's Age Floor to Five; FDA's Is Two Oct 31, 20269 min read Read the story A sunlit colonnade of classical columns, used as a generic regulatory-decision backdrop For Physicians FDA Approves Voceryq, a DNA Immunotherapy for RRP Oct 31, 20268 min read Read the story A classical government building facade with tall columns, a generic stand-in for UK regulatory institutions Drugs & Biologics MHRA Extends Casgevy Gene Therapy to Children Aged Five Oct 31, 20266 min read Read the story A confident executive with arms crossed against a brick wall, a generic stand-in for a company's first regulatory approval Drugs & Biologics FDA Clears Inovio's Voceryq for Airway Papillomas Oct 31, 20266 min read Read the story A modern two-storey white and charcoal building behind a landscaped walkway, the building shown on Aspen Neuroscience's careers page Spotlight Aspen Neuroscience Prices $140.6M Nasdaq IPO Oct 30, 20267 min read Read the story A clinician reviews an anatomical illustration on a tablet with a patient, a generic stand-in for a clinic counseling visit For Physicians CHMP Backs Second Achondroplasia Drug, Dosed Weekly Oct 29, 20267 min read Read the story Classical columns of a government building viewed from below against a blue sky Guidance & Policy FDA Drafts a Path to One BLA Per Gene-Editing Family Oct 28, 20266 min read Read the story A professional wearing glasses and a dark blazer in an office with bookshelves and plants in the background Spotlight Estuary Launches With $103M for Kidney Gene Therapy Oct 21, 20267 min read Read the story A business leader stands in an office with colleagues working in the background Drugs & Biologics Ultragenyx Sells Priority Review Voucher for $210M Oct 11, 20265 min read Read the story A researcher in a hairnet and lab coat adjusts a microscope at a bright laboratory bench Drugs & Biologics Pierre Fabre Refiles Ebvallo BLA After FDA Reversal Oct 4, 20265 min read Read the story A professional in a white blouse signs and stamps documents at a desk beside a laptop For Physicians FAYUVI's Label Limits It to Early-Stage Sanfilippo Sep 28, 20268 min read Read the story A researcher in a lab coat and glasses examines a flask of purple liquid held up to the light Spotlight Cyllene Wins FDA RMAT Status for Bladder Gene Therapy Sep 20, 20266 min read Read the story A researcher wearing safety glasses and a white lab coat looks through a microscope eyepiece while adjusting a sample slide Drugs & Biologics FDA Approves First Gene Therapy for Sanfilippo Type A Sep 18, 20265 min read Read the story Two masked lab researchers review notes on a clipboard while operating a microscope, surrounded by lab glassware Drugs & Biologics FDA Extends Review of Capricor's Duchenne Therapy Aug 24, 20265 min read Read the story A senior scientist in a cleanroom gown and hairnet adjusts a microscope while a gowned colleague assists at the bench Guidance & Policy FDA Finalizes FAQ Guide for Cell, Gene Therapies Aug 23, 20266 min read Read the story The U.S. Supreme Court Building in Washington, D.C., framed by blooming cherry trees under a clear blue sky Drugs & Biologics FDA Approves First Gene Therapy for GSDIa Aug 20, 20266 min read Read the story A scientist in a white lab coat and safety glasses reviews handwritten notes on a clipboard in a laboratory corridor, with a colleague behind her Drugs & Biologics FDA Approves Replimune's Twice-Rejected Melanoma Drug Aug 6, 20266 min read Read the story Two researchers in a laboratory, one examining a sample under a microscope while a colleague works at a fume hood in the background Drugs & Biologics FDA Panel Votes 9-3 Against Capricor's DMD Heart Drug Aug 2, 20266 min read Read the story A researcher wearing glasses looks through a binocular microscope while a colleague in a lab coat stands in the background Drugs & Biologics FDA's Cell Therapy Panel Revisits a Once-Rejected DMD Drug Jul 26, 20266 min read Read the story A scientist at FDA's Center for Biologics Evaluation and Research examining a cell-culture flask under an inverted microscope Drugs & Biologics FDA Sets a July 30 Panel on Replimune's Melanoma Drug Jul 17, 20265 min read Read the story