TOKYO, Japan, 24 July 2020 – Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the expanded approval of CRYSVITA® (burosumab) to include older adolescents and adults living with the rare disease X-linked hypophosphataemia (XLH).
Kyowa Kirin and MEI Pharma announce global licence, development and commercialisation agreement for ME-401
SAN DIEGO, and TOKYO, April 14, 2020 – MEI Pharma, Inc. (NASDAQ: MEIP) and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) today jointly announced that the companies have entered into a global license, development and commercialization agreement to further develop and commercialize MEI’s ME-401, an oral, once-daily, investigational drug-candidate, selective for phosphatidylinositol 3-kinase delta (PI3Kδ), in clinical development for …
Ultragenyx and Kyowa Kirin Announce Health Canada Approval of Crysvita™ (burosumab injection) for the Treatment of X–linked Hypophosphatemia (XLH) in Adults and Children
First Approved Treatment for XLH in Canada that Targets the Underlying Cause of this Rare, Hereditary, Lifelong Disease.
Kyowa Kirin Announces Mogamulizumab Received Positive CHMP Opinion for Treatment of Mycosis Fungoides & Sézary Syndrome
Kyowa Hakko Kirin Co., Ltd., (Kyowa Kirin) announces today that the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency’s (EMA) scientific committee, has adopted a Positive Opinion recommending approval of the marketing authorisation of mogamulizumab
NICE BACKS Crysvita® (burosumab) for RARE METABOLIC BONE DISORDER, X-LINKED HYPOPHOSPHATAEMIA (XLH)
The positive recommendation marks a step change in the management of XLH for children and young people, and the first significant clinical advancement for the condition in the last 35 years.
Kyowa Kirin Announces FDA Approval of Poteligeo® for the Treatment of Mycosis Fungoides and Sézary Syndrome
Kyowa Hakko Kirin Co., Ltd., (Kyowa Kirin) announces today that the U.S. Food and Drug Administration (FDA) has granted approval for Poteligeo®
KKI announce FDA approval
Ultragenyx & KKI today announced that the FDA has approved Crysvita® for the treatment of XLH in adult and paediatric patients one year of age and older.
KKI receives European approval
KKI & Ultragenyx Pharmaceutical announce that Crysvita received a positive European Commission decision granting a conditional marketing authorisation
Significant milestone for KKI
Ultragenyx & Kyowa Kirin announce Burosumab receives positive CHMP opinion for the treatment of X-Linked…
Early Access Programme for KKI
Kyowa Kirin International PLC, a wholly owned subsidiary of Kyowa Hakko Kirin Co., Ltd. (Kyowa Hakko Kirin) today announces Germany’s Federal Institute for…
Kyowa Hakko Kirin President & CEO, Dr. Nobuo Hanai, visits KKI HQ in Galashiels
Borders-based specialty pharmaceutical company, Kyowa Kirin International plc (KKI), hosted Dr. Nobuo Hanai, President and Chief Executive Officer of KKI’s parent company, Kyowa Hakko Kirin Co. Ltd., at the company’s head office in Galashiels this week.
KKI announces positive 24-Week data from adult phase 3 study of burosumab
Ultragenyx, Kyowa Hakko Kirin and Kyowa Kirin International Announce Positive 24-Week Data from Adult Phase 3 Study of Burosumab (KRN23) in X-Linked Hypophosphatemia
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