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