FDA rejection

Union Square in San Francisco during JPM 2026
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JPM26: Sanofi looks ahead to lingering US policy hurdles

Though many challenges from the Trump admin have been addressed, Sanofi still has to settle scrutiny of its vaccines and an unexpected FDA rejection.
Darren Incorvaia Jan 14, 2026 2:28pm
U-turn pivot about-face

Atara, Pierre Fabre receive 2nd US rejection for Ebvallo

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
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