Complete Response Letter

U-turn pivot about-face

Pharma

Atara, Pierre Fabre receive 2nd US rejection for Ebvallo

Atara didn't hold back in criticizing the FDA's rationale, noting that the regulator’s new point of view runs “contrary to the FDA’s prior guidance."

Fraiser Kansteiner Jan 12, 2026 11:30am

jet lag sleep disorder

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

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