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...
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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...
OSAKA, Japan & CAMBRIDGE, Mass. – Takeda (TSE:4502/NYSE:TAK) today announced new interim data from the Phase 1b, open-label, proof-of-concept study of subcutaneous mezagitamab (TAK-079), an anti-CD38 monoclonal antibody with disease-modifying potential, in primary immunoglobulin A (IgA) nephropathy. Data from the study showed that kidney function (eGFR) remained stable in patients...
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...
Results from the Phase 2 RedirecTT-1 study demonstrate deep responses with 78.9 percent overall response rate through dual targeting of GPRC5D and BCMA Data signal potential of novel, off-the-shelf approach in patients with extramedullary disease who face significant unmet needs MILAN, Italy — Johnson & Johnson (NYSE: JNJ) announced today new results from...
Tampere, Finland – Researchers from Tampere University, Finland, and Izmir Institute of Technology, Turkey, have developed an in vitro cancer model to investigate why breast cancer spreads to the bones. Their findings hold promise for advancing the development of preclinical tools to predict breast cancer bone metastasis. Breast cancer is...