FDA rejection

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Biotech

FDA shares CRL for Sanofi MS drug mere weeks after rebuff

Less than two weeks after rejecting Sanofi’s investigational MS drug, the FDA has shared the CRL, citing both efficacy and safety concerns.
Gabrielle Masson Jan 6, 2026 4:30am
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Cycle Pharma scoops up beleaguered rare disease biotech

Dec 12, 2025 9:55am
HeartBeam

HeartBeam swells on turning FDA rejection into ECG clearance

Dec 11, 2025 11:50am
gold arrow pointing upward forward

Replimune's stock spikes 100% on FDA acceptance of resubmission

Oct 20, 2025 5:33pm
end of the road road block shut down closed blocked

FDA snubs Fortress' Zydus-partnered Menkes disease candidate

Oct 1, 2025 12:00pm
Manila folder with CONFIDENTIAL printed on it in red

Capricor responds to cell therapy snub, disputes FDA’s concerns

Sep 9, 2025 11:44am