Complete Response Letter

FDA
Manufacturing

Novo plant issues may mean delays for Regeneron, Scholar Rock

The FDA has tagged Novo Nordisk's plant in Indiana with an OAI label, which is the most severe of its three inspection classifications.
Kevin Dunleavy Oct 13, 2025 3:48pm
Image of a neon sign with the word no lit up next to an unlit yes

Xspray hits FDA wall with new manufacturing-related rejection

Oct 9, 2025 9:23am
end of the road road block shut down closed blocked
Favicon Fierce Biotech

FDA snubs Fortress' Zydus-partnered Menkes disease candidate

Oct 1, 2025 12:00pm
newspaper

Celltrion buy, Rexulti CRL, Glenmark-Hengrui—Fierce Pharma Asia

Sep 26, 2025 10:00am
Biogen

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

Sep 24, 2025 9:51am
red light stoplight

Issues at Novo site delay Scholar Rock's bid for SMA approval

Sep 23, 2025 9:19am