Following the label expansion, AbbVie's (ABBV) Epkinly is the first bispecific antibody approved to treat relapsed/refractory (R/R) follicular lymphoma and R/R diffuse large B-cell lymphoma.
The FDA's CRL to Merck (MRK) and its partner Daiichi Sankyo for the patritumab deruxtecan BLA is based on observations made on inspection of a third-party manufacturing facility.
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