prestige biopharma fda
Scope
Date
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Robotics
Koh Young gets OK from FDA for brain surgery robot
Koh Young Technology Inc., a South Korean developer of 3D optical inspection devices used in electronics manufacturing, said on Monday it got 501K...
Jan 21, 2025 (Gmt+09:00)
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Bio & Pharma
JLK gets OK from FDA for ICH diagnosis solution
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...
Jan 06, 2025 (Gmt+09:00)
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Bio & Pharma
Celltrion obtains approval of Steqeyma from FDA
South Korea's Celltrion Inc. said on Wednesday it received new drug submission (NDS) approval from the Food and Drug Administration (FDA) for Steq...
Dec 18, 2024 (Gmt+09:00)
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Bio & Pharma
GC Biopharma acquires ABO Holding for $96 mn
South Korea’s GC Biopharma Corp. said on Thursday it acquired the US-based medical-grade source blood plasma company ABO Holding Inc. The...
Dec 12, 2024 (Gmt+09:00)
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Bio & Pharma
Noul's miLab registered FDA's Class I
South Korea's Noul Co., an in-vitro diagnostics maker and artificial intelligence (AI)-based blood and cancer diagnostic platforms company, said on ...
Nov 28, 2024 (Gmt+09:00)
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Bio & Pharma
Samsung Biologics wins $668 million CDMO deal with European pharma
Samsung Biologics Co., the world’s largest contract drugmaker, said on Wednesday it has signed two drug manufacturing contracts worth a combin...
Nov 20, 2024 (Gmt+09:00)
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Automobiles
Hyundai Motor releases 2025 Santa Fe
Hyundai Motor Co. said on Tuesday that it released the 2025 Santa Fe, a model year change of its flagship midsize sports utility vehicle (SUV) The A...
Aug 27, 2024 (Gmt+09:00)
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Bio & Pharma
Yuhan’s lung cancer drug clears FDA hurdle for global debut
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...
Aug 21, 2024 (Gmt+09:00)
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Bio & Pharma
Celltrion gets FDA nod for Keytruda copy's phase 3 clinical trials
Celltrion Inc., South Korea’s biosimilar giant, will proceed with phase 3 trials for global blockbuster drug Keytruda’s copycat CT-P51, ...
Aug 12, 2024 (Gmt+09:00)
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Bio & Pharma
GC Biopharma sells HK subsidiary to CR Pharm Group for $254 mn
South Korea’s GC Biopharma Corp. announced on Wednesday that it signed a share purchase agreement (SPA) to sell all its shares in its Hong Kon...
Jul 18, 2024 (Gmt+09:00)
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Bio & Pharma
GC Biopharma exports Alyglo to US
South Korea’s major pharmaceutical company GC Biopharma Corp. announced on Monday that it shipped the initial volume of Alygro, its immunoglob...
Jul 09, 2024 (Gmt+09:00)
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Mergers & Acquisitions
Eugene PE, KDB PE to acquire Boryung Biopharma for $231 million
A consortium of Eugene Private Equity and Korea Development Bank Private Equity will acquire 80% of South Korean vaccine maker Boryung Biopharma Co....
Jun 27, 2024 (Gmt+09:00)
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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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Bio & Pharma
OCI eyes acquisition of US biopharmaceutical company
OCI Holdings Co., South Korea’s largest polysilicon maker, is looking abroad to acquire a biopharmaceutical company in the US in a consortium,...
May 14, 2024 (Gmt+09:00)
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Bio & Pharma
Korea’s Celltrion, SK Biopharmaceuticals benefit from direct US sales
Celltrion Inc. and SK Biopharmaceuticals Co. are witnessing improving sales revenue and profitability by selling their products through their own ma...
Apr 16, 2024 (Gmt+09:00)
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Bio & Pharma
GC Biopharma aims to boost Alyglo sales sixfold in the US
CHEONGJU, North Chungcheong Province -- South Korea’s major pharmaceutical company GC Biopharma Corp. aims to raise the sales of Alyglo, its i...
Feb 28, 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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Bio & Pharma
Biopharma M&As: Next big thing for South Korean manufacturers
When Orion Corp., known for its signature snack cake Choco-Pie, announced a $415 million deal to acquire biotech startup LegoChem Biosciences Inc. l...
Jan 22, 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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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
GC Biopharma breaks ground on blood product plant in Indonesia
South Korea’s GC Biopharma Corp. broke ground on Wednesday on Indonesia’s first blood product plant through technology transfer.Indonesi...
Dec 06, 2023 (Gmt+09:00)
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Bio & Pharma
Hanwha to re-enter biopharma market, targeting biomaterials
South Korea’s Hanwha Group will re-enter the biopharmaceutical market to become the country’s sole producer of tris buffers, a key reage...
Dec 05, 2023 (Gmt+09:00)
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Bio & Pharma
GC Biopharma wins $10 mn order for flu vaccine in Thailand
South Korea's GC Biopharma Corp. announced on Thursday that its flu vaccine GC Flu secured a $10 million order in the upcoming bid by Thailand's Gov...
Nov 23, 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
SK Biopharma’s Cenobamate US patent extended by 2032
South Korea's SK Biopharmaceuticals announced on Friday an extension of its US patent for the epilepsy treatment Cenobamate, now set to expire on Oc...
Nov 10, 2023 (Gmt+09:00)
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