Dong-A ST declared that its biosimilar Imuldosa™ (ustekinumab-srlf/DMB-3115), which references Stelara®, has received approval from the U.S. Food and Drug Administration (FDA).
The FDA has sanctioned Genentech's Itovebi, a focused therapy for advanced hormone receptor-positive, HER2-negative breast cancer that carries a PIK3CA mutation.
Foghorn Therapeutics reports the dosing of its first patient in a Phase 1 trial of FHD-909, a novel oral inhibitor targeting SMARCA2 for solid tumors with SMARCA4 mutations.
TREMFYA® (guselkumab) shows remarkable outcomes in patients with Crohn's disease and ulcerative colitis, both those who haven't received biologics and those who have not responded to them.
Pfizer has revealed encouraging topline findings from the final pre-specified overall survival (OS) assessment of the TALAPRO-2 trial involving TALZENNA® (talazoparib).
Arialys Therapeutics has dosed the initial participants in a Phase 1 clinical trial for ART5803, a targeted therapy aimed at autoimmune neuropsychiatric disorders.