This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.
This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting
Patients receiving Polivy plus R-CHP for DLBCL reported similar health-related quality of life outcomes
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
If approved, it will be the first USFDA-approved immunomodulator for the treatment of Covid-19 in hospitalised patients
No new studies have been requested
If approved, Opdivo plus chemotherapy would be the first neoadjuvant immunotherapy-based option for patients with resectable non-small cell lung cancer in the U.S.
Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years
Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications
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