FDA approval

The Kosdaq market under the Korea Exchange said on Wednesday it has canceled its preliminary approval for InnoGrid Co.’s initial public offeri...

South Korea's Hanwha Ocean Co. said on Thursday it received Approval in Principle (AIP) from classification society ABS for a 40,000 cubic meter liq...

Korean Air Lines Co., South Korea’s No. 1 full-service carrier, expects to gain full approval from the US government by the end of October to ...

HLB Co. and its affiliate stocks tumbled on Friday on news that the South Korean biotech group’s highly anticipated new cancer treatment Rivoc...

South Korea's Samsung Bioepis has received approval from the European Commission to sell Pyzchiva, a biosimilar of the autoimmune disease Stelara.&n...

Hanwha Aerospace Co., South Korea’s answer to Elon Musk’s SpaceX, is spinning off its non-core units to focus on defense and aerospace b...

K Enter Holdings Inc., an umbrella entity of South Korea-based entertainment companies creating original entertainment content and managing related ...

South Korean medical AI company Lunit announced on Thursday that it received the first approval from the High Court of New Zealand for its plan to a...

South Korea’s biopharmaceutical company Aprogen Inc. announced on Monday that its Phase 3 clinical trial for a biosimilar of Herceptin (trastu...

Japan has finally given the nod to the merger between South Korea’s No. 1 full-service carrier Korean Air Lines Co. and No. 2 Asiana Airlines ...

South Korea’s electrics components-to-energy conglomerate LS Group is set to start the securities business as it secured regulatory approval t...

The vast majority of creditors to Taeyoung Engineering & Construction Co. (Taeyoung E&C) have agreed to start debt restructuring for the tro...

South Korea's biotech company MedPacto Inc. announced on Tuesday that it has got approval from the US Food and Drug Administration (FDA) for its I...

South Korea's bio-regenerative medical firm CGBio announced on Tuesday that its Novosis Putty has been designated as a breakthrough device by the US...

South Korean biopharmaceutical company Celltrion Inc. announced on Wednesday that it has applied for CT-P39, a biosimilar of the treatment of asth...

Global healthcare giant Johnson & Johnson is seeking approval for a lung cancer drug developed with Yuhan Corp., bringing the South Korean pha...

South Korean medical diagnostic company NGeneBio Co. announced on Friday that it has received approval for the sale of its in-vitro diagnostic medic...

South Korean genome editing developer ToolGen Inc. announced on Monday that its application for orphan drug designation (ODD) of the gene correction...

South Korea’s GC Biopharma Corp. announced on Monday that it received approval from the US Food and Drug Administration (FDA) for the immuno...

BEIJING – CICC Capital, a unit of China International Capital Corp. (CICC), has entered the South Korean market with the launch of a private e...

South Korea's SK Bioscience Co. announced on Monday that it submitted the Investigational New Drug (IND) application for the Phase 3 clinical trial ...

South Korean biopharmaceutical company Celltrion Inc. announced on Friday that it applied for approval from the European Medicines Agency (EMA) for ...

SK Biopharmaceuticals Co. is gearing up to explore the European market for its flagship epilepsy drug Cenobamate, while looking for new mergers and ...

South Korean medical AI company Lunit said on Tuesday its Lunit Insight DBT, an AI imaging diagnosis solution aiding in breast cancer diagnosis, has...

SK Energy Co., a unit of South Korean oil refiner and battery maker SK Innovation Co., is spinning off its crude oil storage and shipment business t...

South Korean cosmetics giant Amorepacific Corp. said on Thursday its camellia-derived cosmetic ingredients got COSMetic Organic and natural Standard...

South Korean biotech company Gencurix Inc. announced on Wednesday its subsidiary GenoBio has received approval from the US Food and Drug Admini...

South Korea's Woori Bank plans to open two new branches in India in the first half of next year. The bank announced on Tuesday it has obtained ...

South Korea’s Hanwha Ocean Co. on Sunday announced its conclusion of a basic accord with the Houston-based American Bureau of Shipping (ABS) t...

HD Korea Shipbuilding & Offshore Engineering and HD Hyundai Heavy Industries Co. have secured Approval in Principle (AIP) from the UK's Lloyd's ...