FDA rejection

KT&G Corp., South Korea’s dominant tobacco and ginseng producer, is seeking to acquire a Japanese ginseng company after dismissing a 1.9-t...

Koh Young Technology Inc., a South Korean developer of 3D optical inspection devices used in electronics manufacturing, said on Monday it got 501K...

South Korea’s JLK Inc., an AI-based diagnosis solution and platform maker, said on Monday it got 501K approval from the US Food and Drug Admin...

South Korea's Celltrion Inc. said on Wednesday it received new drug submission (NDS) approval from the Food and Drug Administration (FDA) for Steq...

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South Korea's Noul Co., an in-vitro diagnostics maker and artificial intelligence (AI)-based blood and cancer diagnostic platforms company, said on ...

South Korean tobacco maker KT&G Corp. on Thursday unveiled a plan to buy back shares and pay dividends totaling 3.7 trillion won ($2.7 billion) ...

Singapore-based investment management firm Flashlight Capital Partners Pte. (FCP) has offered to buy South Korean tobacco maker KT&G Corp.'s gin...

Elliott Investment Management Corp. has lost a case against Samsung C&T Corp. in seeking 26.7 billion won ($20.2 million) compensation in connec...

KCC Corp., a paint and glass maker but better known as a white knight for South Korean conglomerates, holds more than 4 trillion won ($3 billion) wo...

A new lung cancer treatment developed by South Korea’s Yuhan Corp. has secured approval from the US Food and Drug Administration (FDA) as a co...

Celltrion Inc., South Korea’s biosimilar giant, will proceed with phase 3 trials for global blockbuster drug Keytruda’s copycat CT-P51, ...

South Korea’s JLK Inc., an AI-based diagnosis solution and platform maker, announced on Monday that it got approval from the US Food and Drug ...

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

Hanwha Ocean Co., the world’s second-largest shipbuilder, said on Tuesday it made a takeover bid for Austal and negotiated the price and terms...

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

South Korea has slammed the brakes on BlackRock’s offshore wind farm project worth around 10 trillion won ($7.5 billion), citing financing unc...

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...

Kakao Mobility Corp.’s ambition to go global has hit a roadbock after its parent group Kakao Corp. rejected its draft bid to buy Germany-based...

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...

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

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...

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

NKMax Co., South Korea's largest developer of natural killer (NK) cell therapies, will conduct its first clinical trials in the US for its candidate...

Byooviz, a biosimilar of the macular degeneration treatment Lucentis and made by South Korea’s Samsung Bioepis, has received official design...

South Korea's Celltrion Inc. announced on Monday it received a new drug approval for an autoimmune disease treatment Remsima SC (active ingredient i...

South Korea's medical device startup Vuno announced on Tuesday that its AI-powered brain quantification device Vuno Med-DeepBrain has received the 5...