FDA Urges Caution Following Boxed Warning Requirements on CAR T-Cell Therapies
January 25th 2024FDA leadership notes that the overall rate of secondary T-cell cancers among patients administered CAR T-cell therapies appears to be low, even if all reported cases are assumed to be related to treatment.
FDA Issues Complete Response Letter to Theratechnologies sBLA for New Formulation of Tesamorelin
January 25th 2024Theratechnologies said it will address the FDA’s complete response letter and will continue to seek approval for the new formulation of tesamorelin for the treatment of lipodystrophy in patients also diagnosed with HIV.
Bristol Myers Squibb Completes Acquisition of Mirati to Bolster Oncology Pipeline
January 24th 2024Under the agreement, Bristol Myers Squibb obtains Mirati’s entire portfolio, including Krazati (adagrasib) for the treatment of KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer.
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.