FDA rejection
Scope
Date
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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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Tech, Media & Telecom
S.Korean supreme court upholds $800 mn fine against Qualcomm
South Korea’s Supreme Court on Thursday reaffirmed the country’s largest-ever penalty of 1.03 trillion won ($800 million) imposed on Qua...
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
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
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
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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Artificial intelligence
S.Korea rejects patent claims for AI-invented products
South Korea’s intellectual property office has rejected patent applications that claimed an artificial intelligence system as their inventor, ...
Oct 04, 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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Cryptocurrencies
Terra founder Do Kwon vows to communicate proactively with press
Terraform Labs' founder and CEO Do Kwon has reemerged on Twitter, after making his account private for a couple of days. Two weeks after Terra&...
Jun 10, 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)
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Bio & Pharma
Korea Hanmi to launch blockbuster hypertension drug in China
South Korea’s Hanmi Pharmaceutical Co. is set to launch its blockbuster high blood pressure drug Amosartan in China, the world’s largest...
Mar 11, 2022 (Gmt+09:00)
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Beauty & Cosmetics
LG Household’s China strategy put to test as shares crash
LG Household & Health Care Ltd.’s shares have been flying high since its market debut in 2001, and have more recently basked in the global...
Jan 10, 2022 (Gmt+09:00)
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COVID-19
Celltrion wins COVID-19 treatment approval from Europe
South Korea’s pharmaceutical giant Celltrion Inc. has won final approval for its COVID-19 treatment Regkirona from the European Commission, a ...
Nov 15, 2021 (Gmt+09:00)
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Biosimilars
Samsung Bioepis gets FDA approval for Lucentis biosimilar Byooviz
Samsung Bioepis Co., a leading South Korean biopharmaceutical company, has received approval from the US Food and Drug Administration for its Byoovi...
Sep 23, 2021 (Gmt+09:00)
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Mergers & Acquisitions
Hahn & Co. sues Namyang owner over completion of $267 mn deal
South Korea’s private equity firm Hahn & Co. filed a lawsuit against the owner of Namyang Dairy Products and his family to complete a $267...
Aug 30, 2021 (Gmt+09:00)
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