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Complete Response Letter
Fierce Biotech
Stealth CEO questions FDA rejection of rare disease drug
“We are kind of hanging on by our fingernails here to try to bring this drug to the patient community,” Stealth CEO Reenie McCarthy told Fierce Biotech.
Gabrielle Masson
May 29, 2025 2:27pm
Regeneron's Eylea franchise stumbles on several fronts in Q1
Apr 29, 2025 2:50pm
Novo, Merck, Hengrui-Elevar—Fierce Pharma Asia
Mar 28, 2025 9:28am
FDA rejects Milestone’s nasal spray citing manufacturing issues
Mar 28, 2025 8:42am
FDA rejects Hengrui, Elevar's PD-1 cancer drug combo—again
Mar 21, 2025 3:25pm
Axsome secures hard-fought FDA nod for migraine drug Symbravo
Jan 31, 2025 8:18am