The PRIOH-1 study met its primary endpoint, delivering statistically significant and clinically meaningful improvements in lesion healing
Waskyra is an ex vivo gene therapy that uses patients’ own CD34+ hematopoietic stem and progenitor cells, genetically engineered with a lentiviral vector
LOTTE Biologics will provide advanced manufacturing services for monoclonal antibody intermediates and their conjugates
The decision positions Yartemlea as the first and only approved inhibitor of the lectin pathway of complement
Approval broadens indication for Tezspire to a second disease characterized by epithelial-driven inflammation
Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma
Reblozyl is a standard of care for the first-line treatment of anemia without previous erythropoiesis stimulating agent use
ANVIMO will be available in dosages of 240 mg and 480 mg
Approval is based on positive data from the Phase 3 ECHELON-3 trial
Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone
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