hlb sofjec fda
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Date
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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)
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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
HLB starts Phase 3 clinical trials for ophthalmic disease treatment in US
South Korea's pharmaceutical company HLB Therapeutics Co. announced on Thursday that it has started patient administration of "RGN-259," a treatment...
Apr 13, 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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Bio & Pharma
HLB Cell develops organoid biomaterial based on human normal cells
HLB Cell, a subsidiary of HLB Life Science Co., which specializes in the development of cell therapy products, announced on April 4 that it succeede...
Apr 06, 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
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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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
HLB’s Rivoceranib, Hengrui's Camrelizumab approved as combination therapy in China
South Korea's HLB Co. announced on Thursday that the combination therapy of its drug candidate rivoceranib and Jiangsu Hengrui Pharmaceuticals Co., ...
Feb 09, 2023 (Gmt+09:00)
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Bio & Pharma
GC Cell's AB-101 NK therapy achieves FDA fast-track status
South Korea's bio firm GC Cell announced on Wednesday that its US affiliate Artiva Biotherapeutics has received fast-track designation from the US F...
Feb 02, 2023 (Gmt+09:00)
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Bio & Pharma
GC Biopharma's Sanfilippo treatment eligible for FDA priority review
GC Biopharma Corp. said on Wednesday that its Sanfilippo type A treatment, which is under joint development with Novel Pharma, a bio-venture special...
Jan 18, 2023 (Gmt+09:00)
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Bio & Pharma
MedPacto's anti-cancer substance designated as US FDA fast-track item
South Korean biotech company MedPacto Inc. ’s Vactosertib monotherapy for osteosarcoma patients has been designated as a fast-track developmen...
Jan 18, 2023 (Gmt+09:00)
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Bio & Pharma
HLB confirms ophthalmic disease treatment in phase 3 clinical trials
South Korea’s biomedicine startup HLB Therapeutics Co. said on Monday that its Neurotrophic Keratopathy (NK) treatment RGN-259 proved effectiv...
Jan 03, 2023 (Gmt+09:00)
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Bio & Pharma
CJ applies to FDA for trials of immuno-anticancer drug candidate
CJ Bioscience, an independent red bio (pharmaceutical and healthcare) subsidiary of CJ CheilJedang Corp., said on Monday it has submitted a phase 1 ...
Dec 26, 2022 (Gmt+09:00)
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Bio & Pharma
Celltrion applies for FDA approval for Remsima SC
Celltrion Ltd. said on Friday it had applied the previous day for permission from the US Food and Drug Administration (FDA) for Remsima SC, an autoi...
Dec 23, 2022 (Gmt+09:00)
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Bio & Pharma
HLB Therapeutics signs contract for COVID vaccine distribution rights
South Korea's pharmaceutical firm HLB Therapeutics Co. said on Monday that it has signed an agreement with the Korea Disease Control and Prevention ...
Dec 20, 2022 (Gmt+09:00)
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Bio & Pharma
Celltrion to seek FDA approval for sale of Remsima SC by year-end
Celltrion Inc. said it has confirmed the effectiveness and safety of Remsima SC in its third-phase global clinical trials, conducted on 438 patients...
Nov 28, 2022 (Gmt+09:00)
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Bio & Pharma
Mezzion Pharma to try again for US FDA approval of drug
South Korea's Mezzion Pharma will seek to get the oral medicine Udenafil to treat side effects from heart surgery, planning to clinical trials in th...
Nov 23, 2022 (Gmt+09:00)
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Mergers & Acquisitions
Korea's LG Chem buys Nasdaq-listed biotech firm AVEO for $566 mn
South Korea’s chemicals giant LG Chem Ltd. announced on Oct. 18 that it will acquire AVEO Pharmaceuticals Inc., a Nasdaq-listed US biotech fir...
Oct 18, 2022 (Gmt+09:00)
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Bio & Pharma
Hanmi’s anti-cancer drug Rolontis gets FDA approval; US sale via Spectrum
South Korea’s Hanmi Pharmaceutical Co. said on Tuesday that Rolontis, an anti-cancer drug it has jointly developed with its US partner, has ob...
Sep 13, 2022 (Gmt+09:00)
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Bio & Pharma
LG Chem receives FDA nod for CUE-102 cancer treatment phase 1 trials
LG Chem Life Sciences, the biopharmaceutical unit of LG Chem Ltd., has received the US Food and Drug Administration’s approval for phase 1 cli...
May 13, 2022 (Gmt+09:00)
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Bio & Pharma
Medytox-Hugel dispute over botox strain intensifies with ITC probe
A legal dispute over a botox strain between South Korean pharmaceutical company Medytox Inc. and its crosstown rival Hugel Inc. has intensified with...
May 03, 2022 (Gmt+09:00)
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Bio & Pharma
FutureChem seeks FDA nod for prostate cancer radiopharma trials
FutureChem Co., a South Korean radiopharmaceutical company, is seeking the US Food and Drug Administration’s approval for clinical tests of it...
Apr 20, 2022 (Gmt+09:00)
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Bio & Pharma
FDA to review Hanmi Pharmaceutical’s Rolontis for marketing approval
The US Food and Drug Administration has begun reviewing a medicine developed by South Korea’s Hanmi Pharmaceutical Co. for marketing authoriza...
Apr 13, 2022 (Gmt+09:00)