Complete Response Letter

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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
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FDA plans to release more CRLs as controversial policy resumes

Jul 14, 2026 2:50pm
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FDA releases 14 drug rejection letters after 3-month pause

Jul 13, 2026 11:01am
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FDA halts release of new drug rejection letters

Jul 8, 2026 1:33pm
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FDA snubs Sobi’s gout drug over manufacturing issues

Jun 29, 2026 11:04am