SEOUL, June 9 (Korea Bizwire) — South Korea’s financial regulator on Wednesday granted the final approval for a new internet-only bank, a move that could further fuel competition with established bigger players. The Financial Services Commission (FSC) gave the approval to the consortium led by South Korean fintech firm Viva Republica, which operates the popular [...]
SEOUL, Oct. 22 (Korea Bizwire) — Korea Shipbuilding & Offshore Engineering Co. said Thursday that it and its unit Hyundai Mipo Dockyard Co. have won approval for the design of a commercial hydrogen carrier for the first time in the world. The approval in principle for the design was awarded by KR, South Korea’s ship [...]
SEOUL, April 21 (Korea Bizwire) — Samsung Electronics Co. said Tuesday its blood pressure monitoring mobile application has earned medical device approval in South Korea. The Ministry of Food and Drug Safety has granted the Software as a Medical Device (SaMD) license to its health monitoring app, according to Samsung. The software leverages a smartwatch’s [...]
JEJU, Dec. 5 (Korea Bizwire) — South Korea’s first for-profit hospital received the final approval from the Jeju Special Self-Governing Province on Wednesday, putting an end to 16 years of controversy over the introduction of investor-owned medical institutions. Jeju Gov. Won Hee-ryong announced the approval of the Greenland International Hospital as a for-profit hospital on [...]
Stratford-upon-Avon, UK, Jun. 8 (Korea Bizwire) – Celixir, a privately owned company discovering and developing life-saving advanced therapies, announces that the US Food and Drug Administration (FDA) has approved its Investigational New Drug application (IND) for HeartcelTM, its immuno-modulatory progenitor (iMP) cell therapy for the treatment of adult heart failure. Celixir announced in January the approval [...]
SEOUL, Aug. 25 (Korea Bizwire) — South Korean biopharmaceutical firm Samsung Bioepis Co. said Friday it has won approval from European authorities for the sale of its biosimilar drug Imraldi. The European Commission (EC) accepted Samsung Bioepis’ application to sell the biosimilar referencing AbbVie Inc.’s Humira, the company said in a regulatory filing. The drug [...]