FDA rejection

Image of a neon sign with the word no lit up next to an unlit yes

Pharma

Xspray hits FDA wall with new manufacturing-related rejection

It's the third FDA complete response letter for Xspray during its repeated attempts to launch Dasynoc, a leukemia med based on a BMS' blockbuster.

Zoey Becker Oct 9, 2025 9:23am

end of the road road block shut down closed blocked

Fierce Biotech

FDA snubs Fortress' Zydus-partnered Menkes disease candidate

Oct 1, 2025 12:00pm

Biogen

Biogen undeterred after FDA snub for high-dose Spinraza in SMA

Sep 24, 2025 9:51am

Graphic image of a red thumbs down against a blue background

Otsuka, Lundbeck's Rexulti snubbed by FDA in PTSD

Sep 22, 2025 4:42pm

paper paperclips

FDA's response letter salvo sheds light on drug refusal process

Jul 11, 2025 10:15am

Eylea HD

Regeneron's Eylea franchise stumbles on several fronts in Q1

Apr 29, 2025 2:50pm