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Complete Response Letter
Pharma
FDA rejects Hengrui, Elevar PD-1 liver cancer combo a 3rd time
The FDA has declined to approve Hengrui and Elevar’s anti-PD-1/VEGFR combo in first-line liver cancer for a third time.
Angus Liu
Jul 10, 2026 10:55am
Fierce Biotech
FDA halts release of new drug rejection letters
Jul 8, 2026 1:33pm
Unicycive approval filing turned away by FDA again
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
