Complete Response Letter

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Manufacturing

ITM cancer drug spurned by FDA over manufacturing qualms

The problems lie not with ITM-11's efficacy or safety but with its CMC and with a third-party commercial facility.
Darren Incorvaia Aug 10, 2026 11:25am
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Novo’s Catalent plant ditched in FDA refiling of SMA drug

Aug 10, 2026 10:06am
FDA

2 FDA citations trouble Hengrui, Elevar’s liver cancer combo

Jul 28, 2026 3:02pm
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After 3 CRLs, FDA approves Outlook's AMD drug Lytenava

Jul 27, 2026 11:51am
FDA stop sign

FDA rejects Hengrui, Elevar PD-1 liver cancer combo a 3rd time

Jul 10, 2026 10:55am
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FDA halts release of new drug rejection letters

Jul 8, 2026 1:33pm