prestige biopharma fda
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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)
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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
GC Biopharma inks $90mn deal for blood products in Brazil
South Korea's GC Biopharma Corp. on Monday announced on Monday that it has a supply contract with Blau Farmacêutica, a Brazilian pharmaceutica...
Jul 03, 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
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
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
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
CrystalGenomics to sell largest 20% stake to Invites Healthcare for $44 mn
CrystalGenomics Inc., South Korea’s first-generation biopharma venture company, will sell new shares worth 58 billion won ($44 million) in a b...
May 23, 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
Merck to build biopharma raw material plant in Korea
Global pharmaceutical company Merck is considering a plan to establish a biopharmaceutical raw material production facility in Daejeon.South Korean ...
May 03, 2023 (Gmt+09:00)
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Bio & Pharma
Verismo's CAR-T therapy designated fast-track status by FDA
Verismo Therapeutics, a US affiliate of South Korean pharmaceutical firm HLB Co., has received fast-track designation from the US Food and Drug Admi...
Apr 07, 2023 (Gmt+09:00)
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Mergers & Acquisitions
Dongwon backs out of Boryung Biopharma buyout deal
Dongwon Industries Co., South Korea’s No. 1 canned tuna producer, has backed out of a deal estimated between $400 million and $500 million to ...
Mar 23, 2023 (Gmt+09:00)
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Bio & Pharma
GC Biopharma wins $44 mn flu vaccine order from WHO agency
South Korea's pharmaceutical firm GC Biopharma Corp. said on Monday that it has won a $44.3 million (57.9 billion won) order for flu vaccines in a d...
Mar 21, 2023 (Gmt+09:00)
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Bio & Pharma
Prestige Bio's pancreatic cancer treatment gets US FDA fast-track designation
Prestige Biopharma, a biopharmaceutical company in South Korea, announced on Thursday that their pancreatic cancer antibody drug, PBP1510 (Ulenistam...
Mar 16, 2023 (Gmt+09:00)
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Robotics
Korean 3D tech firm Koh Young looks to US medical robot market
Koh Young Technology Inc., a South Korean developer of 3D optical inspection devices used in electronics manufacturing, is slated to enter the US me...
Mar 15, 2023 (Gmt+09:00)
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Robotics
Curexo unveils artificial joint surgery robot TMAX at AAOS 2023
Curexo, a South Korean medical robot company, said on Tuesday that it had unveiled its artificial joint surgery robot "TMAX" at AAOS 2023, the world...
Mar 15, 2023 (Gmt+09:00)
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Bio & Pharma
S.Korea's Prestige Biologics attracts $59 mn overseas investment
Prestige Biologics Co., a South Korean biopharmaceutical contract development and manufacturing organization (CDMO) company, announced on Tuesday th...
Mar 15, 2023 (Gmt+09:00)
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Bio & Pharma
GC Biopharma's licensed flu vaccine gets approval in Taiwan
South Korea's pharmaceutical firm GC Biopharma Corp. announced on Monday that its quadrivalent flu vaccine has received marketing approval from the ...
Mar 13, 2023 (Gmt+09:00)
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Bio & Pharma
GC Biopharma to develop mRNA flu vaccine with Canadian pharma
South Korea's GC Biopharma Corp. announced on Thursday that it will start developing a flu vaccine based on messenger ribonucleic acid (mRNA).The dr...
Mar 09, 2023 (Gmt+09:00)
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Bio & Pharma
GC Biopharma introduces candidates for treating blood coagulation disease
South Korea's GC Biopharma Corp. announced on Tuesday that it had entered into an agreement to transfer assets with Catalyst Biosciences, a US-based...
Mar 02, 2023 (Gmt+09:00)
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Bio & Pharma
Daewoong’s Nabota expands into Germany, Austria
South Korean drugmaker Daewoong Pharmaceutical Co. said on Tuesday it had launched its botulinum toxin product Nabota in Germany and Austria through i...
Mar 02, 2023 (Gmt+09:00)
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Bio & Pharma
Jetema applies to test its botulinum toxin in US from July
South Korea's bio-esthetic pharmaceutical company Jetema Co. will hold clinical trials in the US to advance to the American market, the world's bigg...
Feb 27, 2023 (Gmt+09:00)
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Mergers & Acquisitions
Dongwon solo bidder for Boryung Biopharma estimated at $385 mn
South Korea’s leading seafood and logistics conglomerate Dongwon Group is seeking to buy local biopharmaceutical company Boryung Biopharma Co....
Feb 24, 2023 (Gmt+09:00)
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Bio & Pharma
GC Biopharma gets WHO pre-qualification approval for chickenpox vaccine
South Korea's GC Biopharma Corp. is set to regain the No. 1 spot in global production of chickenpox vaccines after earning qualification to enter th...
Feb 21, 2023 (Gmt+09:00)
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Bio & Pharma
S.Korea's Hwajin Medical gets FDA sales approval for syringes
HLB Therapeutics Co. announced Thursday that Sofjec, a syringe produced by its subsidiary Hwajin Medical, has been approved for sale by the US Food ...
Feb 17, 2023 (Gmt+09:00)
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Bio & Pharma
GC Biopharma, Sanofi to jointly market Plavix
GC Biopharma Co. (formerly Green Cross Corp.) said on Monday it has entered into a joint sales partnership with Sanofi-Aventis Korea, the South Kore...
Feb 13, 2023 (Gmt+09:00)