FDA approval
Scope
Date
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Earnings
KT earnings beat estimates in Q2; shares hit 6-month high
KT Corp., South Korea’s leading telecommunications carrier, reported better-than-expected earnings in the second quarter on strong results for...
Aug 07, 2023 (Gmt+09:00)
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Banking & Finance
KB Kookmin Bank launches integrated bank in Cambodia
South Korea’s KB Kookmin Bank on Sunday said it received final approval on Friday from Cambodia’s Ministry of Commerce to launch the int...
Aug 07, 2023 (Gmt+09:00)
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Logistics
CJ Logistics to enter global pharmaceutical transportation market
South Korea’s CJ Logistics on Wednesday said it obtained the certification CEIV Pharma, or the Center of Excellence for Independent Validators...
Jul 26, 2023 (Gmt+09:00)
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Bio & Pharma
Raphas microneedle passes US FDA's cGMP inspection
South Korea's microneedle maker Raphas Co. announced on Wednesday that it has passed the Current Good Manufacturing Practice (cGMP) inspection by ...
Jul 26, 2023 (Gmt+09:00)
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Bio & Pharma
GC Biopharma wins approval for quadrivalent flu vaccine in Egypt
South Korea's GC Biopharma Corp. announced on Wednesday that its quadrivalent influenza vaccine "GC Flu Quadrivalent" has received approval from Egy...
Jul 19, 2023 (Gmt+09:00)
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Bio & Pharma
Corentec enters Japanese artificial joint market
Corentec Co., a South Korean company that develops artificial joints and spinal implants, is making a full-fledged entry into the Japanese market. T...
Jul 18, 2023 (Gmt+09:00)
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Bio & Pharma
Ildong Bioscience gets US FDA OK for probiotic raw materials
South Korea's Ildong Bioscience on Thursday said two of its probiotic raw materials received the certification generally recognized as safe (GRAS) f...
Jul 14, 2023 (Gmt+09:00)
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Bio & Pharma
Celltrion applies for approval in US for eye treatment biosimilar
South Korean biopharmaceutical company Celltrion Inc. on Friday said it applied for approval from the US Food and Drug Administration (FDA) for CT-P...
Jun 30, 2023 (Gmt+09:00)
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Bio & Pharma
LegoChem Bio receives FDA approval for phase 1,2 trials of LCB84
South Korean pharmaceutical firm LegoChem Biosciences Inc. announced on Thursday that it has received approval from the US Food and Drug Administrat...
Jun 23, 2023 (Gmt+09:00)
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Bio & Pharma
Huons’ 2% lidocaine gets approval from FDA
South Korean pharmaceutical firm, Huons Co., announced on Monday that it has secured another significant regulatory milestone in the US with the Foo...
Jun 19, 2023 (Gmt+09:00)
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Bio & Pharma
Daehwa Pharm applies for approval of anti-dementia patch in China
South Korea's Daehwa Pharm Co. is speeding up its advance into the Chinese market for anti-dementia medicine, applying for sales approval of its pat...
Jun 16, 2023 (Gmt+09:00)
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Bio & Pharma
Celltrion wins phase 3 IND approval for Ocrevus biosimilar in US
South Korea's biopharmaceutical company Celltrion Inc. announced that it received on Thursday approval from the US Food and Drug Administration (FDA...
Jun 15, 2023 (Gmt+09:00)
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Electronics
Galaxy Watch's alarm of abnormal heartbeat gets approval in S.Korea
Samsung Electronics Co.'s new feature on the Galaxy Watch, which detects heartbeats and alerts the possibility of risks such as arrhythmia, can now ...
Jun 15, 2023 (Gmt+09:00)
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Bio & Pharma
S.Korea’s top pharmaceutical distributor buys 25% of No. 2 Baekje Pharma
South Korea’s top pharmaceutical distributor Geo-young Co. has acquired 25% of market No. 2 Baekje Pharmaceutical.Geo-young on Tuesday said th...
Jun 14, 2023 (Gmt+09:00)
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Bio & Pharma
Hanmi Pharm's Efinopegdutide gets Fast Track Designation from FDA
Merck, known as MSD outside the United States and Canada, announced on Monday that Efinopegdutide, a technology transferred from the South Korean ph...
Jun 13, 2023 (Gmt+09:00)
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Bio & Pharma
Celltrion to expand biosimilar portfolio to 11 by 2025
South Korea's biopharmaceutical company Celltrion Inc. announced on Tuesday that it plans to beef up its portfolio by applying for regulatory approv...
Jun 13, 2023 (Gmt+09:00)
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Airlines
Korean Air says it can conclude Asiana takeover via big concessions
The head of Korean Air Lines Co. has expressed confidence over the airliner's proposed acquisition of Asiana Airlines, saying, "We will make it happ...
Jun 07, 2023 (Gmt+09:00)
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Bio & Pharma
GC Biopharma wins contract to build blood products plant in Indonesia
GC Biopharma Corp., a South Korean pharmaceutical company, announced on Thursday that it has received approval from the Indonesian Ministry of Healt...
Jun 02, 2023 (Gmt+09:00)
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Bio & Pharma
Samsung Bioepis gets approval to sell biosimilar in Europe
South Korea's Samsung Bioepis has received approval in Europe to sell a biosimilar of Soliris, a drug for the treatment of adult and children patien...
May 31, 2023 (Gmt+09:00)
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Bio & Pharma
SK Bioscience’s COVID-19 vaccine gets approval in UK
SK Bioscience Co., the drug-making unit of South Korea’s SK Group, said on Monday that its domestic COVID-19 vaccine, SKYCovione, has rec...
May 30, 2023 (Gmt+09:00)
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Bio & Pharma
Celltrion gets FDA approval for Humira biosimilar CT-P17
South Korean biopharmaceutical company Celltrion Inc. announced on Wednesday that it has obtained product approval from the US Food and Drug Adminis...
May 24, 2023 (Gmt+09:00)
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Bio & Pharma
HLB submits new drug application to FDA for Rivoceranib liver cancer drug
HLB Co. announced on May 17 that it has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for the approval of Rivo...
May 19, 2023 (Gmt+09:00)
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Bio & Pharma
FDA suspends COVID-19 diagnostic kit of S.Korea’s SD Biosensor
The US Food and Drug Administration (FDA) has recommended that consumers discard select models of Pilot COVID-19 self-diagnostic test kits sold on t...
May 08, 2023 (Gmt+09:00)
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Chemical Industry
CJ CheilJedang gets FDA approval for biodegradable packaging material
South Korea's largest food and bio company CJ CheilJedang Corp. announced on Thursday that its biodegradable material polyhydroxyalkanoate (PHA) has...
May 04, 2023 (Gmt+09:00)
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Bio & Pharma
SK Biopharmaceuticals gets marketing approval for epilepsy drug in Israel
South Korea’s SK Biopharmaceuticals said on Wednesday that the Israeli Ministry of Health has approved the company's new drug application (NDA...
May 03, 2023 (Gmt+09:00)
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Mergers & Acquisitions
Korea clears way for Hanwha's $1.45 bn takeover of DSME
South Korea’s Fair Trade Commission (FTC) on Thursday gave its nod for Hanwha Group’s 2-trillion-won ($1.45 billion) takeover of Daewoo ...
Apr 27, 2023 (Gmt+09:00)
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The KED View
In South Korea, innovation is subject to regulatory approval
In a country like South Korea with few natural resources to run its economy, innovations or brilliant business ideas are crucial to its survival.It ...
Apr 26, 2023 (Gmt+09:00)
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Bio & Pharma
CG Bio establishes US corporation to develop tissue products
South Korean bio-regenerative medical firm CG Bio has launched a new US corporation CG MedTech, to focus on the development and marketing of tissue ...
Apr 25, 2023 (Gmt+09:00)
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Food & Beverage
Kolmar BNH gets approval for health functional food ingredient in US
Kolmar BNH Co. has received approval from the US Food and Drug Administration (FDA) for a domestically developed health functional food ingredient.K...
Apr 20, 2023 (Gmt+09:00)
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Bio & Pharma
Welt gets second digital therapeutic device approval in S. Korea
South Korea's Ministry of Food and Drug Safety announced on Wednesday that it has approved the cognitive therapy software "WELT-I" developed by We...
Apr 19, 2023 (Gmt+09:00)