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The Food and Drug Administration ( FDA ) has granted accelerated approval to Tecvayli ( Teclistamab;Teclistamab-cqyv ), the first bispecific B-cell maturation antigen ( BCMA )-directed CD3 T-cell enga ...


The FDA ( Food and Drug Administration ) has approved the Biologics License Application ( BLA ) for Tzield ( Teplizumab-mzwv; Teplizumab ), an anti-CD3-directed antibody, for intravenous use, as the f ...


The U.S. Food and Drug Administration ( FDA ) has approved Relyvrio ( Sodium Phenylbutyrate / Taurursodiol ) to treat patients with amyotrophic lateral sclerosis ( ALS ), commonly referred to as Lou G ...


The U.S. Food and Drug Administration ( FDA ) has approved a supplemental New Drug Application ( sNDA ) for the oral androgen receptor inhibitor ( ARi ) Darolutamide ( Nubeqa ) in combination with Doc ...


The FDA ( Food and Drug Administration ) has approved Pyrukynd ( Mitapivat ) tablets to treat hemolytic anemia in adults with pyruvate kinase ( PK ) deficiency. PK deficiency is an inherited disord ...


The Food and Drug Administration ( FDA ) has approved Enhertu ( fam-Trastuzumab Deruxtecan-nxki; Trastuzumab Deruxtecan ) for adult patients with unresectable or metastatic HER2-low ( IHC 1+ or IHC 2+ ...


The European Commission ( EC ) has granted conditional marketing authorisation ( CMA ) of Tecvayli ( Teclistamab ) as monotherapy for the treatment of adult patients with relapsed and refractory multi ...


The European Commission ( EC ) has granted conditional marketing authorization for Minjuvi ( Tafasitamab ) in combination with Lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult ...


The FDA ( Food and Drug Administration ) has approved Opzelura ( Ruxolitinib) cream for the treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. Opzelura is a ...


The U.S. Food and Drug Administration ( FDA ) has approved Tibsovo ( Ivosidenib ) in combination with Azacitidine for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemi ...


The U.S. Food and Drug Administration ( FDA ) has approved Mounjaro ( Tirzepatide ) injection to improve blood glucose control in adults with type 2 diabetes, as an addition to diet and exercise. Mo ...


The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has issued a positive opinion recommending approval of a new treatment option with Ibrutinib ( Imbr ...


The European Commission ( EC ) has granted conditional marketing authorisation for the CD20xCD3 T-cell engaging bispecific antibody Lunsumio ( Mosunetuzumab ), for the treatment of adult patients with ...


The European Commission ( EC ) has granted approval of Polivy ( Polatuzumab vedotin ) in combination with Rituximab plus Cyclophosphamide, Doxorubicin, and Prednisone ( R-CHP ) for the treatment of ad ...


The U.S. Food and Drug Administration ( FDA ) has approved Mounjaro ( Tirzepatide ) injection to improve blood glucose control in adults with type 2 diabetes, as an addition to diet and exercise. Mo ...