FDA rejection

jet lag sleep disorder
Pharma

FDA rejects Vanda's Hetlioz for a 2nd time in jet lag disorder

For the second time, the FDA has rejected Vanda’s bid to expand the label for Hetlioz to treat jet lag disorder.
Kevin Dunleavy Jan 8, 2026 11:20am
An envelope with rejected mark Vector illustration
Favicon Fierce Biotech

FDA shares CRL for Sanofi MS drug mere weeks after rebuff

Jan 6, 2026 4:30am
Regeneron

FDA rejects Eylea HD for ongoing manufacturing issues

Oct 28, 2025 11:52am
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
Biogen

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

Sep 24, 2025 9:51am