If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy
Submission to be reviewed under FDA real-time oncology review and Project Orbis
If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure
The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer
Jemperli is the only immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression
Pfizer plans to submit an sBLA by the end of this year, subject to discussions with U.S. FDA
Acceptance based on results from the phase 3 KEYNOTE-091 trial
Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved
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