Approvals
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.
Approved under the regulator’s accelerated pathway, Tecelra is also the first new synovial sarcoma therapy in more than a decade, according to Adaptimmune Therapeutics.
In pursuit of Merck’s blockbuster Keytruda, GSK’s Jemperli scored its own broad FDA label expansion, allowing its use in first-line endometrial cancer regardless of biomarker status.
The FDA has four big events in the coming two weeks, including an advisory panel meeting for an ultra-rare disease.
The South Korean company’s Epysqli is now FDA-approved for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome in the U.S., having grabbed the lead in the Soliris biosimilar market in Europe.
Already approved for erosive gastroesophageal reflux disease, Phathom’s Voquenza is now authorized to treat patients with non-erosive GERD.
PRESS RELEASES