Vertex and CRISPR Therapeutics announce USFDA approval of Casgevy for treatment of sickle cell disease
Approximately 16,000 patients 12 years of age and older with severe sickle cell disease may now be eligible for this one-time treatment
Approximately 16,000 patients 12 years of age and older with severe sickle cell disease may now be eligible for this one-time treatment
Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone
Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients
KEYTRUDA is the first immunotherapy approved in the EU for the first-line treatment of this patient population
SKYSCRAPER-01 is ongoing and the study remains blinded to patients and investigators
ELREXFIO’s label contains a boxed warning for cytokine release syndrome and neurologic toxicity
If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU
Oncodesign Services and ImaginAb sign a Preclinical License and Supply Agreement
Columvi is part of Roche's industry-leading portfolio of T-cell engaging bispecific antibodies in non-Hodgkin lymphoma, which also includes the recently approved Lunsumio to treat follicular lymphoma
Sun Pharma will have exclusive rights to commercialise Nidlegy for indications of skin cancers in the territories of Europe, Australia and New Zealand. Philogen will complete pivotal clinical trials for the product in Europe
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