US FDA extends review timeline of Regenxbio’s BLA for clemidsogene lanparvovec to treat Mucopolysaccharidosis II: Rockville, Maryland Wednesday, August 20, 2025, 18:00 Hrs [IST] ...

The US Food and Drug Administration (FDA) has extended Regenxbio’s review timeline of the Biologics License Application (BLA) ...

The extension was needed to review newly submitted long-term clinical data for all patients in the pivotal study following an FDA information request.

Delays from the Food and Drug Administration continue to pile up, with Maryland-based Regenxbio the latest to report the review of one of its assets ...

Sarah Hunter, the Red Roses defence coach, believes this month’s Women’s Rugby World Cup will attract more women into ...

The FDA has postponed its decision date for Regenxbio’s Hunter syndrome gene therapy to review additional longer-term ...

RGX-121 would be the first and only potential one-time commercially-available therapy designed to directly address the underlying genetic cause of Hunter syndrome ...

RegenXBio ( ($RGNX) ) has issued an announcement. On August 18, 2025, REGENXBIO announced that the FDA has extended the review timeline for its ...

REGENXBIO Inc. (Nasdaq: RGNX) today announced that the U.S. Food and Drug Administration (FDA) extended its review timeline of the Biologics License Application (BLA) for clemidsogene lanparvovec (RGX ...

Susan Boyle Singing "I Dreamed a Dream" Again Caused a Mid-Performance Ovation Judge strikes down Trump administration ...

Denali Therapeutics posts narrower-than-expected Q2 loss. The company advances multiple rare disease therapies toward potential approvals.

Tividenofusp alfa BLA for Hunter syndrome accepted for priority review and assigned PDUFA target action date of January 5, 2026; company preparing for commercial launchDNL126 accelerated approval path ...