The filing is based on the results from an investigator-initiated Japanese phase II clinical study evaluating Tecentriq in combination with carboplatin and paclitaxel, the standard chemotherapy regimen for unresectable thymic carcinoma as first-line treatment Designated as an orphan drug, making it eligible for priority review If approved, Tecentriq would become...
treatment News
TOKYO, Japan — Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it launched ELEVIDYS® Intravenous Infusion [generic name: delandistrogene moxeparvovec] (hereinafter, “ELEVIDYS”), which received conditional and time-limited approval on May 13, 2025, following its listing on the national health insurance (NHI) reimbursement price list today, as a regenerative medical product for...
TOKYO, Japan — Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it launched “LUNSUMIO® for intravenous infusion 1 mg” and “LUNSUMIO® for intravenous infusion 30 mg” (generic name: mosunetuzumab (genetical recombination)) (hereafter, LUNSUMIO), antineoplastic agent / anti-CD20/CD3 humanized bispecific antibody for the treatment of patients with relapsed or refractory follicular lymphoma who have...
TOKYO, Japan — Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq® Intravenous Infusion [generic name: atezolizumab (genetical recombination)] for an additional indication of unresectable thymic carcinoma. Tecentriq received orphan drug designation...
TOKYO, Japan — Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it has obtained regulatory approval from the Ministry of Health, Labour and Welfare for “Evrysdi® Tablets 5mg,” a new formulation of the spinal muscular atrophy (SMA) treatment Evrysdi [generic name: risdiplam]. Evrysdi is currently the only orally administered treatment for...
TOKYO, Japan — Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that data from Part C of the Phase I/II NXTAGE study, the first clinical data evaluating NXT007 in people switching from emicizumab without a washout period, were presented at the 2026 European Association for Haemophilia and Allied Disorders (EAHAD) Congress held...
Duchenne muscular dystrophy is a rare genetic muscle disorder with poor life prognosis, which is difficult to cure and significantly reduces independent living and quality of life due to muscle weakness Approval based on results from clinical studies including a global Phase III clinical study (EMBARK) Approval for ambulatory patients...
SAN DIEGO, Calif. — Cidara Therapeutics Inc. (Nasdaq: CDTX), a biotechnology company developing therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has approved REZZAYO (rezafungin acetate) for the...
CRANFORD, N.J. — Citius Oncology, Inc. (“Citius Oncology”) (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. (“Citius Pharma”) (Nasdaq: CTXR), today announced the commercial launch of LYMPHIR™ (denileukin diftitox-cxdl). LYMPHIR is a novel IL-2 receptor-directed fusion protein approved by the U.S. Food and Drug Administration (FDA) for the treatment of...
CRANFORD, N.J. — Citius Oncology, Inc. (“Citius Oncology”) (Nasdaq: CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. (“Citius Pharma”) (Nasdaq: CTXR), today announced positive topline safety and efficacy results from an investigator‑initiated Phase 1 trial evaluating LYMPHIR™ (E7777, denileukin diftitox‑cxdl) administered prior to commercial CD19‑directed CAR‑T therapy in...