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Complete Response Letter
Manufacturing
Unicycive approval filing turned away by FDA again
Unicycive is optimistic the third-party manufacturing facility can meet FDA standards to support an approval, CEO Shalabh Gupta, M.D., said.
Eric Sagonowsky
Jun 30, 2026 9:03am
FDA snubs Sobi’s gout drug over manufacturing issues
Jun 29, 2026 11:04am
Cingulate hit with manufacturing-related FDA rejection
Jun 2, 2026 9:53am
Outlook wins FDA appeal after formal dispute proceedings
May 27, 2026 8:26am
Gilead's once-rejected hepatitis D med wins FDA nod
May 26, 2026 9:49am
AbbVie, Grace Therapeutics receive manufacturing-related CRLs
Apr 24, 2026 11:37am
