The FDA issued a third complete response letter for ONS-5010/Lytenava, requesting confirmatory efficacy evidence for wet AMD treatment. Lytenava is an ophthalmic bevacizumab formulation, potentially ...
LYTENAVA has marketing authorisation in EU and UK for wet AMD from European Commission and MHRA. Credit: New Africa/Shutterstock.com. Outlook Therapeutics has received the US Food and Drug ...
The FDA closed out 2025 with a pair of complete response letters, cratering the share prices of Corcept Therapeutics and Outlook Therapeutics. Both companies reported that the agency had rejected a ...
Dec 31 (Reuters) - Outlook Therapeutics (OTLK.O), opens new tab said on Wednesday the U.S. health regulator has declined to approve its drug for a type of eye disease, dealing another blow in the ...
Atezolizumab plus bevacizumab and chemotherapy did not significantly improve PFS compared with placebo (6.4 vs 6.7 months) in patients with advanced ovarian cancer. Atezolizumab in combination with ...
JSKN003 received breakthrough therapy designation for treating platinum-resistant ovarian, peritoneal, and fallopian tube cancers with HER2 expression. Clinical trials showed a 63% objective response ...