OSAKA, Japan & CAMBRIDGE, Mass. – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) announced that a safety signal has emerged in Phase 2 studies of TAK-994, an investigational oral orexin agonist. As an immediate precautionary measure, the company has suspended dosing of patients and has decided to stop both Phase 2...
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OSAKA, Japan & CAMBRIDGE, Mass. — Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved FRUZAQLA™ (fruquintinib), an oral targeted therapy for adults with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS...
CAMBRIDGE, Mass. – As part of its commitment to reducing burdens facing the rare disease community, Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced three priority policy reforms and solutions designed to address significant barriers to care for patients managing rare diseases and genetic conditions as part of a new...
OSAKA, Japan – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for lanadelumab subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of hereditary angioedema (HAE). HAE is a rare genetic...
OSAKA, Japan and CAMBRIDGE Massachusetts – The FDA on Thursday approved Takeda’s recombinant ADAMTS13, now to be marketed as Adzynma, for the treatment of the rare blood disorder congenital thrombotic thrombocytopenic purpura—the biopharma company’s second approval in as many days. Adzynma is indicated as an intravenous prophylactic and on-demand therapy...
OSAKA, Japan & CAMBRIDGE, Mass. – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) has approved EXKIVITY (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20...
OSAKA, Japan & CAMBRIDGE, Mass. — Takeda today announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID® [Immune Globulin Infusion (Human) 10% solution] as an intravenous immunoglobulin (IVIG) therapy to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). It can be...
Seven years ago, when their son first started having seizures, Dean and Amy Kriebel found that their finances were stretched to the limit due to hospital bills and special adaptive equipment for young Andrew. “Just after his first birthday, he had his first seizure,” Dean Kriebel said. “Things spun out...
Adelaide, Australia – A new approach to treating the most malignant type of brain cancer – glioblastoma – has shown strong promise in pre-clinical settings, raising hopes of increasing current average survival rates beyond 18 months. Targeted alpha therapy (TAT) is emerging as a potential additional treatment for glioblastoma (GB),...
A combination of two targeted cancer drugs showed unprecedented, “clinically meaningful” activity in patients with highly malignant brain tumors that carried a rare genetic mutation, according to a clinical trial report by investigators from Dana-Farber Cancer Institute. The drug combination, which blocked an overactive cell-growth signaling pathway, shrank tumors by...