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.
AbbVie (NYSE: ABBV) announced today the acquisition of Celsius Therapeutics, Inc. ("Celsius"), a privately held biotechnology company pioneering new therapies for patients with inflammatory disease. Celsius' lead investigational asset is CEL383, a potential first-in-class anti-TREM1 antibody that has completed a Phase 1 clinical study for the treatment of IBD.