Complete Response Letter

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

Fierce Biotech

FDA shares CRL for Sanofi MS drug mere weeks after rebuff

Jan 6, 2026 4:30am

milestone milestone pharmaceuticals

FDA signs off on Milestone's heart arrhythmia nasal spray

Dec 15, 2025 8:20am

red light stop light street traffic signal

Alvotech plant issues trigger another FDA biosimilar rejection

Nov 4, 2025 7:40am

Regeneron

FDA rejects Eylea HD for ongoing manufacturing issues

Oct 28, 2025 11:52am

FDA

Novo plant issues may mean delays for Regeneron, Scholar Rock

Oct 13, 2025 3:48pm