The FDA approved AbbVie’s once-daily tavapadon, branded Juvmo, for adults with Parkinson’s disease with or without levodopa. The decision creates the first approved selective D1/D5 receptor agonist and is supported by three randomized Phase…
Kodiak Sciences reported that both Zenkuda and tabirafusp alfa tedromer met the one-year visual-acuity noninferiority endpoint versus aflibercept in the approximately 690-patient Phase 3 DAYBREAK study. Fifty-four percent of Zenkuda-treated patients reached a 24-week…
Adicet reported Phase 1 data for prulacabtagene leucel, an allogeneic gamma-delta anti-CD20 CAR-T therapy, in systemic lupus erythematosus with or without lupus nephritis. At 12 months, 54% of evaluable patients achieved DORIS remission and…
Daiichi Sankyo and Merck voluntarily withdrew the U.S. accelerated-approval application for ifinatamab deruxtecan in previously treated extensive-stage small-cell lung cancer after FDA discussions concluded that the supporting data, including Phase 2 IDeate-Lung01, did not…
In the initial 20-patient cohort A subgroup of Phase 2 CARTITUDE-2, ten patients remained alive and progression-free five years after one cilta-cel infusion and without maintenance therapy. At 60.7 months median follow-up, five-year overall…
FDA approved oral belzutifan plus lenvatinib for advanced clear-cell RCC after PD-1 or PD-L1 therapy. In the 747-patient randomized Phase 3 LITESPARK-011 study, the combination reduced the risk of progression or death by 26%…
A peer-reviewed Phase 1 study of anitocabtagene autoleucel reported responses in all 38 treated patients with heavily pretreated relapsed or refractory multiple myeloma, including 79% complete responses. At 38.1 months median follow-up, median progression-free…
The FDA approved lirafugratinib, branded Lyrfigtu, for adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or rearrangement. In the single-arm REFOCUS study of 116 FGFR-inhibitor-naive patients, independently reviewed…
Kyverna reported 12-month durability from the 26-patient KYSA-8 registrational study in stiff person syndrome and longer follow-up from seven generalized myasthenia gravis patients. Median timed 25-foot walk improvement in SPS was 49% at Month…
Both remigromig doses met the Week 52 noninferiority endpoint versus ranibizumab for change in best-corrected visual acuity in the 984-participant BRUNELLO trial. Merck also disclosed higher rates of proliferative diabetic retinopathy, vitreous hemorrhage and…
