April 21st 2025
Nigel McCracken, chief operating officer, Virax Biolabs explains how the ViraxImmune PAIS assay uses T cell responses and cytokine levels to detect immune dysfunction and identify viral triggers of chronic inflammation.
Astellas Announces Submission of sNDA for Padcev/Keytruda Combo for Urothelial Cancer
January 31st 2024Approval sought for Padcev (enfortumab vedotin) plus Keytruda (pembrolizumab) for the first-line treatment of adults with previously untreated locally advanced or metastatic urothelial cancer, which would be the first approved combination alternative to platinum-containing chemotherapy for this patient population.
FDA Approves Takeda's Gammagard Liquid for Chronic Inflammatory Demyelinating Polyneuropathy
January 30th 2024This is Takeda's second approval in chronic inflammatory demyelinating polyneuropathy this month after the FDA approved HyQvia to protect against relapse of neuromuscular disability and impairment in this patient population.
Sarepta's Novel Drug for Duchenne Muscular Dystrophy Shows Favorable Efficacy to Eteplirsen
January 30th 2024SRP-5051 administered every four weeks produced higher increases in dystrophin and exon skipping compared to eteplirsen dosed weekly in patients with Duchenne muscular dystrophy amenable to exon 51 skipping.
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.