Approvals
Nearly two weeks ahead of its target action date, the regulator on Wednesday has signed off on Incyte and Syndax’s Niktimvo for the third-line treatment of graft-versus-host disease.
The European Union has approved the first-ever combination therapy consisting of an immunotherapy and a PARP inhibitor for the treatment of endometrial cancer, AstraZeneca announced Wednesday.
The Swiss company’s monoclonal antibody Nemluvio is also undergoing regulatory review for atopic dermatitis, which is a potentially larger market for the first-in-class IL-31 blocker.
Ascendis Pharma’s palopegteriparatide was previously rejected by the regulator due to manufacturing problems, and the review period for its resubmitted application was extended by three months.
ARS Pharma’s neffy on Friday became the first FDA-approved nasal spray to address severe allergic reactions, including those that might lead to life-threatening anaphylaxis.
Citius Pharmaceuticals’ Lymphir is a reformulated version of denileukin diftitox—an FDA-approved cancer therapy—and the only treatment for cutaneous T cell lymphoma that targets the IL-2 receptor located on malignant T cells and Tregs.
Fabhalta is approved for the treatment of IgAN patients who are at risk of rapid disease progression, which is indicated by a urine protein-to-creatinine ratio of at least 1.5 g/g.
Crexont was previously rejected by the regulator in June 2023, citing insufficient safety data. However, Amneal Pharmaceuticals’ resubmission included findings from a healthy volunteer study.
Servier Pharmaceuticals’ vorasidenib on Tuesday secured the FDA’s green light for the treatment of patients with grade 2 gliomas carrying mutations in the IDH gene.
With U.S. election season now in full swing, BioSpace looks at pharmaceutical-associated campaign contributions. Plus, Q2 earnings, Adaptimmune’s big approval, an anticipated FDA decision on an MDMA-assisted treatment and more.
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