The Phase 2 trial, conducted through Starton’s Sargon Site Network, is expanding from two to six sites across the U.S.
BLA is based on a robust data package supporting similarity to Orencia (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data
Both non-transfusion-dependent and transfusion dependent cohorts met their respective primary and secondary endpoints
The drug’s safety profile in LIBRETTO-432 aligned with previous selpercatinib studies, showing no unexpected concerns
The designation for HCB101covers all forms of gastric cancer, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative patients
The recommendation is based on new data from continuous safety monitoring of medicines in the EU
KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to its components
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