prestige biopharma fda
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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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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
Prestige Biologics partners with Indian company for CDMO
Prestige Biologics Co., a South Korean biopharmaceutical contract development and manufacturing organization (CDMO) company, is expanding its CDMO b...
Sep 22, 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
EuBiologics, GC Biopharma to jointly produce cholera vaccine
South Korea's EuBiologics Co., the world's leading cholera vaccine company, has signed a joint production agreement with GC Biopharma Corp. to produ...
Aug 25, 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
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
Prestige Biopharma participates in US gov’t Cancer Moonshot
Prestige Biopharma, a Singapore-based biopharmaceutical company with operations in South Korea and the US, announced on Tuesday that it will partici...
Jul 18, 2023 (Gmt+09:00)