Tag Archives: MHLW

Boehringer Ingelheim expands global rollout of JASCAYD® following Japan approval for pulmonary fibrosis treatment

(IN BRIEF) Boehringer Ingelheim has received approval from Japan’s Ministry of Health, Labour and Welfare for JASCAYD® (nerandomilast) to treat adults with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. The oral PDE4B inhibitor is the first therapy of its kind … Read the full press release

Sanofi Receives Orphan Drug Designation in Japan for Rilzabrutinib to Treat IgG4 Related Disease

(IN BRIEF) Sanofi has obtained orphan drug designation in Japan for rilzabrutinib as a treatment for IgG4-related disease, a rare immune-mediated condition with limited treatment options. The designation from Japan’s Ministry of Health, Labour and Welfare is supported by positive … Read the full press release

AstraZeneca’s Truqap Gets Green Light in Japan for Advanced Breast Cancer Treatment

(IN BRIEF) AstraZeneca announces the approval of Truqap (capivasertib) in combination with Faslodex (fulvestrant) by the Japanese Ministry of Health, Labour, and Welfare (MHLW) for treating adult patients with unresectable or recurrent hormone receptor-positive, HER2-negative breast cancer. The approval, based … Read the full press release

Sanofi’s ALTUVIIIO Granted Marketing Authorization in Japan for Hemophilia A Treatment

(IN BRIEF) The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for ALTUVIIIO, a novel factor VIII replacement therapy used to control bleeding in patients with hemophilia A. ALTUVIIIO, also known as efanesoctocog alfa, stands out … Read the full press release

Japanese Ministry of Health, Labour and Welfare (MHLW) granted approval for GSK’s Nucala® as a treatment for bronchial asthma

LONDON, 29-Mar-2016 — /EuropaWire/ — GlaxoSmithKline plc (LSE/NYSE:GSK) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for Nucala® (mepolizumab) as a treatment for bronchial asthma in patients with refractory asthma whose symptoms are inadequately … Read the full press release