Manufacturing

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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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Merck prepares expanded access to monthly PrEP pill early

Jul 24, 2026 10:40am
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FDA snubs Sobi’s gout drug over manufacturing issues

Jun 29, 2026 11:04am
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Medline earns FDA warning letter ire for repeat bacteria issues

Jun 4, 2026 7:36am
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Lilly, Boehringer slash investment plans in Germany

Jun 3, 2026 3:10pm