Sandoz to Acquire Interchangeable Lucentis Biosimilar Cimerli
January 22nd 2024The biosimilar Cimerli carries the interchangeability designation for the treatment of wet age-related macular degeneration, diabetic macular edema, macular edema following retinal vein occlusion, myopic choroidal neovascularization, and diabetic retinopathy.
FDA Approves Balversa for Locally Advanced, Metastatic Urothelial Carcinoma
January 19th 2024Today's FDA approval amends a previously granted accelerated approval for Balversa (erdafitinib) to treat patients with metastatic urothelial carcinoma whose tumors harbor FGFR3 or FGFR2 alterations following prior platinum-based chemotherapy.
Novartis' Lutathera Shows Significant Survival Benefit as First-Line Treatment for GEP-NETs
January 19th 2024Lutathera plus long-acting release octreotide lowered the risk of disease progression or death by 72% in patients with somatostatin receptor-positive well-differentiated grade 2/3 advanced gastroenteropancreatic neuroendocrine tumors.
FDA Fast Tracks Nurix Therapeutics, Inc’s Novel BTK Inhibitor for CLL, SLL
January 18th 2024NX-5948 is under evaluation for for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma following at least two lines of therapy that includes a BTK inhibitor and a BCL2 inhibitor.
Gene-Edited Cell Therapy Casgevy Gains FDA Approval for Transfusion-Dependent Beta Thalassemia
January 17th 2024Vertex Pharmaceuticals' and CRISPR Therapeutics’ Cas9 therapy Casgevy approved as a one-time treatment for transfusion-dependent beta thalassemia on the heels of its approval last month for sickle cell disease.