FDA rejection
Scope
Date
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Bio & Pharma
JLK gets FDA OK for prostate cancer diagnosis AI solution
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 ...
Jun 25, 2024 (Gmt+09:00)
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Bio & Pharma
Investors dump Korean biotech HLB stocks on FDA rejection
HLB Co. and its affiliate stocks tumbled on Friday on news that the South Korean biotech group’s highly anticipated new cancer treatment Rivoc...
May 17, 2024 (Gmt+09:00)
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Mergers & Acquisitions
Hanwha committed to Austal takeover deal despite rejected bid
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...
Apr 03, 2024 (Gmt+09:00)
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Bio & Pharma
Aprogen gets OK Phase 3 trials in India for Herceptin biosimilar
South Korea’s biopharmaceutical company Aprogen Inc. announced on Monday that its Phase 3 clinical trial for a biosimilar of Herceptin (trastu...
Feb 05, 2024 (Gmt+09:00)
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Energy
Korea rejects BlackRock’s $7.5 bn wind farm project
South Korea has slammed the brakes on BlackRock’s offshore wind farm project worth around 10 trillion won ($7.5 billion), citing financing unc...
Jan 30, 2024 (Gmt+09:00)
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Bio & Pharma
MedPacto gets FDA OK for colorectal cancer drug clinical trial
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...
Jan 03, 2024 (Gmt+09:00)
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Bio & Pharma
CGBio gets FDA approval for Novosis Putty
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...
Jan 02, 2024 (Gmt+09:00)
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Mergers & Acquisitions
Kakao Mobility's talks to acquire FreeNow in deadlock
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...
Dec 27, 2023 (Gmt+09:00)
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Bio & Pharma
ToolGen gets FDA approval for TGT-001 as ODD
South Korean genome editing developer ToolGen Inc. announced on Monday that its application for orphan drug designation (ODD) of the gene correction...
Dec 18, 2023 (Gmt+09:00)
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Bio & Pharma
GC Biopharma gets FDA approval for Alyglo
South Korea’s GC Biopharma Corp. announced on Monday that it received approval from the US Food and Drug Administration (FDA) for the immuno...
Dec 18, 2023 (Gmt+09:00)
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Bio & Pharma
SK Bioscience applies Phase 3 trials in US for pneumococcal vaccine
South Korea's SK Bioscience Co. announced on Monday that it submitted the Investigational New Drug (IND) application for the Phase 3 clinical trial ...
Dec 11, 2023 (Gmt+09:00)
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Bio & Pharma
SK Biopharm gears up to boost epilepsy drug sales in Europe
SK Biopharmaceuticals Co. is gearing up to explore the European market for its flagship epilepsy drug Cenobamate, while looking for new mergers and ...
Nov 16, 2023 (Gmt+09:00)
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Artificial intelligence
Lunit gets FDA approval for AI cancer diagnosis solution
South Korean medical AI company Lunit said on Tuesday its Lunit Insight DBT, an AI imaging diagnosis solution aiding in breast cancer diagnosis, has...
Nov 14, 2023 (Gmt+09:00)
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Bio & Pharma
Gencurix gets FDA OK for breast cancer prognosis analysis device
South Korean biotech company Gencurix Inc. announced on Wednesday its subsidiary GenoBio has received approval from the US Food and Drug Admini...
Nov 08, 2023 (Gmt+09:00)
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Bio & Pharma
NKMax to perform first tests on dementia cell therapy in US
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...
Oct 26, 2023 (Gmt+09:00)
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Bio & Pharma
Samsung Bioepis gets FDA OK for its interchangeable biosimilar
Byooviz, a biosimilar of the macular degeneration treatment Lucentis and made by South Korea’s Samsung Bioepis, has received official design...
Oct 25, 2023 (Gmt+09:00)
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Bio & Pharma
Celltrion gets FDA approval for Remsima SC
South Korea's Celltrion Inc. announced on Monday it received a new drug approval for an autoimmune disease treatment Remsima SC (active ingredient i...
Oct 23, 2023 (Gmt+09:00)
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Artificial intelligence
Vuno's brain imaging AI medical device secures FDA certification
South Korea's medical device startup Vuno announced on Tuesday that its AI-powered brain quantification device Vuno Med-DeepBrain has received the 5...
Oct 10, 2023 (Gmt+09:00)
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Bio & Pharma
Yungjin Pharm's new drug candidate gets Fast Track from FDA
South Korea's Yungjin Pharm has secured Fast Track designation from the US Food and Drug Administration (FDA) for its new drug candidate KL1333, des...
Sep 06, 2023 (Gmt+09:00)
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Bio & Pharma
Hugel resubmits application to FDA for botulinum toxin product
South Korea's biopharmaceutical company Hugel Inc., announced on Friday that it has resubmitted applications to the US Food and Drug Administration ...
Sep 01, 2023 (Gmt+09:00)
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Bio & Pharma
S.Korea's CGBio gets FDA approval for spinal implant
CGBio, a South Korean bio-regenerative medical company, announced on Monday that its "Advanced LumFix spinal fixation system," an implant and surgic...
Aug 14, 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
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
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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Regulations
S.Korea rejects Broadcom’s corrective steps on unfair biz
South Korea’s antitrust body dismissed corrective measures proposed by US chipmaker Broadcom Inc. to avoid penalties over its alleged unfair b...
Jun 13, 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 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)