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

FDA Delays Decision Date For Denali Therapeutics' Lead Drug Candidate

Denali Denali Therapeutics FDA
FDA Expands Surprise Inspections At Foreign Food And Drug Plants

The U.S. Food and Drug Administration extended on Monday Denali Therapeutics Inc.’s (NASDAQ:DNLI) review timeline of the Biologics License Application (BLA), seeking accelerated approval of tividenofusp alfa for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome.

• DNLI is in negative territory. Track the latest developments here.

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
A battered 1677 wooden cabinet sold for $1.64 million after a key photo revealed its rarity
A small carved oak cabinet made in Salem, Massachusetts, in 1677 reached Sotheby’s as a few photographs submitted through its online portal. To an untrained eye, it might have looked like a grungy old box. Then Erik Gronning, a senior advisor in Sotheby’s American Furniture, Folk Art and Decorative Arts…
The Times of India
The Times of India
63 Hilarious And Concerning Times People Misused Quotation Marks And Made It Weird
We’ve probably all witnessed the havoc a misplaced comma can wreak on an innocent sentence. “Let’s eat, Grandma” and “Let’s eat Grandma” are one small mark apart, but only one of them sounds like a line from Hannibal Lecter. But there’s another punctuation mishap we see all the time, on…
Bored Panda
Bored Panda
73 Marriage Tweets That Prove Living With Someone Is A Daily Exercise In Accepting Weirdness
The science behind finding a partner's quirks endearing, the psychology of oversharing with strangers, and the research on couples who laugh together all point to the same conclusion: the public is not just content. It is proof of something lasting. Check out the full list of tweets to realise that…
Bored Panda
Bored Panda
The Beach Boys’ Mike Love returns to the stage despite ‘facing serious health challenges’
The 85-year-old was helped on stage by actor John Stamos, who shared an emotional message about his ‘musical hero and mentor’
The Guardian - AU
The Guardian - AU
Columbia woman spends $10 on a tiny Chipotle burrito and complains online. Then she finds out she allegedly offended the entire ‘burrito community’
That's a character-building experience.
We Got This Covered
We Got This Covered
Kelly Clarkson Slams Brooklyn Store After Being Treated Like She Couldn't Afford Its Products in 'Pretty Woman' Moment
Kelly Clarkson says an Art of Play employee treated her as though she could not afford its products. The Brooklyn shop has shared positive reviews but has not publicly explained the encounter.
International Business Times UK
International Business Times UK
Fourteen days free
Download the app
One app. One membership.
100+ trusted global sources.
Download on the AppStore Get it on Google Play