Tag Archives: Approval

Sanofi’s Sarclisa Receives Approval in China for Newly Diagnosed Multiple Myeloma Treatment

(IN BRIEF) Sarclisa (isatuximab) has been approved in China for use in combination with the VRd regimen to treat newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant. The approval is based on positive results from … Read the full press release

Enhertu Gains Conditional Approval in China for Advanced HER2-Positive Gastric Cancer Treatment

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Enhertu has received conditional approval in China for treating locally advanced or metastatic HER2-positive gastric cancer, following promising results from the DESTINY-Gastric06 trial. This marks the third approval for Enhertu in China in less … Read the full press release

Dupixent® Receives Landmark Approval in Japan for Chronic Spontaneous Urticaria Treatment

(IN BRIEF) Japan’s Ministry of Health, Labor and Welfare (MHLW) has authorized the marketing and manufacturing of Dupixent® (dupilumab) for treating chronic spontaneous urticaria (CSU) in patients aged 12 years and older. This approval marks a significant milestone as Japan … Read the full press release

Wärtsilä’s Aquarius UV Ballast Water Management System submitted for US Coastguard Type Approval following completion of required testing procedures

HELSINKI, 08-Nov-2018 — /EuropaWire/ — The technology group Wärtsilä’s Aquarius UV Ballast Water Management System (BWMS) has successfully completed all the required testing procedures, and has now been submitted for US Coastguard (USCG) Type Approval. This follows the International Maritime Organization’s (IMO) Type … Read the full press release