Get all your news in one place.
100's of premium titles.
One app.
Start reading
Benzinga
Benzinga
Business
Vandana Singh

REVEALED: Fda extends decision date on regenxbio s gene therapy into next year - The Real Truth

FDA Regenxbio Gene Therapy
REGENXBIO Inc

The U.S. Food and Drug Administration (FDA) on Monday extended its review timeline for REGENXBIO Inc.’s (NASDAQ:RGNX) Biologics License Application (BLA) for clemidsogene lanparvovec (RGX-121) for Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome.

The Prescription Drug User Fee Act (PDUFA) goal date has been extended from November 9, 2025, to February 8, 2026.

Sign up to read this article
Read news from 100's of titles, curated specifically for you.
Already a member? Sign in here
Related Stories
Top stories on inkl right now
One subscription that gives you access to news from hundreds of sites
Already a member? Sign in here
Our Picks
'End of the World' Is 12 Days Away, According to 1960 Study Resurfacing Online
A 1960 study suggesting humanity's population would approach infinity on 13 November 2026 has resurfaced online, but it was a mathematical projection, not an apocalypse prediction.
International Business Times UK
International Business Times UK
China imports millions of donkey hides from Africa every year: new book traces the drivers and impact
The demand for donkey hides has grown exponentially over the past 15 years, driven mainly by demand from China. Lauren Johnston is a specialist on China trade with Africa. She has spent several years looking into the donkey trade, and has just published a book, China, Africa and the Market…
The Conversation
The Conversation
I’m sick of smug celebrities on the podcast circuit. No wonder there’s a fuss when someone speaks the truth
It was so refreshing to hear Aaron Sorkin admit he was bad at parts of directing after his movie flop. If only others could be as frank, says writer Imogen West-Knights
The Guardian - UK
The Guardian - UK
Zendaya, Cara Delevingne and Justin Bieber among stars celebrating Halloween
The stars showcased their elaborate costumes on social media.
Evening Standard
Evening Standard
Heidi Klum reveals Halloween costume as her iconic party marks 25 years
Heidi Klum underwent a bloody transformation to become a giant, gruesome severed hand for Halloween
The Independent UK
The Independent UK
Keke Palmer and Son Leo Recreate the Jacksons' 'Scream' Style for Halloween—and Janet Responds
Keke Palmer and son Leo recreated Janet and Michael Jackson's "Scream" style for Halloween 2026, earning a response from Janet herself.
Fashion Times
Fashion Times
Fourteen days free
Download the app
One app. One membership.
100+ trusted global sources.
Download on the AppStore Get it on Google Play