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BioWorld - Sunday, April 26, 2026
Home » South Korea

Articles Tagged with ''South Korea''

Bridge Biotherapeutics receives MFDS approval for EGFR drug in lung cancer

May 8, 2020
By Gina Lee
HONG KONG – South Korea’s Bridge Biotherapeutics Inc. wrapped up the week by announcing its awaited IND clearance for its epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, BBT-176, for non-small-cell lung cancer (NSCLC) from the country’s Ministry of Food and Drug Safety (MFDS) on May 7.
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Microscope image of SARS-CoV-2

Osang becomes first Korean company to win FDA emergency authorization

April 21, 2020
By Gina Lee
HONG KONG – South Korea’s Osang Healthcare Co. Ltd. became the first Korean company to receive the U.S. FDA’s emergency use authorization (EUA) for its COVID-19 test kit.
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Microscope image of SARS-CoV-2

Osang becomes first Korean company to win FDA emergency authorization

April 20, 2020
By Gina Lee
HONG KONG – South Korea’s Osang Healthcare Co. Ltd. became the first Korean company to receive the U.S. FDA’s emergency use authorization (EUA) for its COVID-19 test kit. In a letter dated April 18, 2020, the FDA informed Osang of its authorization for the company’s Genefinder COVID-19 Plus Realamp Kit.
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South Korean won

KEXIM seeks managers for its new $328M health care fund

April 10, 2020
By Gina Lee
The Korea Export Import Bank (KEXIM) took a step toward fulfilling its mandate to finance Korean companies’ overseas expansion by seeking managers for a new ₩400 billion (US$328 million) fund.
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Antibody

Celltrion reaches milestone on COVID-19 super antibody

March 24, 2020
By Gina Lee
HONG KONG – Korean biopharma Celltrion Inc. said it’s halfway through the process of creating a super antibody to reign in the COVID-19 novel coronavirus that has claimed almost 13,000 lives globally.
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Two South Korean COVID-19 kits look overseas, seek FDA approval

March 24, 2020
By Gina Lee
HONG KONG – As the number of COVID-19 confirmed cases and deaths continue to rise globally, South Korea’s focus on testing has attracted international attention. Two diagnostic kits made by domestic companies Seegene Inc.and Kogene Biotech Co. Ltd. are currently preparing to apply for U.S FDA approval.
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Antibody

Celltrion reaches milestone on COVID-19 super antibody

March 23, 2020
By Gina Lee
HONG KONG – Korean biopharma Celltrion Inc. said it’s halfway through the process of creating a super antibody to reign in the COVID-19 novel coronavirus that has claimed almost 13,000 lives globally.
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South Korean shield, coronavirus

South Korea approves first four COVID-19 test kits under urgent-use license

March 17, 2020
By Gina Lee
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted the first urgent-use licenses to four COVID-19 novel coronavirus diagnostic kits to battle the pandemic in the country, which is home to one of the largest outbreaks in the world outside of China.
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Stephen Hahn, FDA commissioner

FDA’s Hahn says need to deploy test for SARS-CoV-2 across platforms delayed development

March 11, 2020
By Mark McCarty
U.S. FDA commissioner Stephen Hahn appeared before a congressional panel to discuss the administration’s budget proposal for the agency, but the outbreak of COVID-19 predictably dominated the proceedings.
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Kaipharm secures $4.2M in series A funding for drug-induced transcriptome database

Feb. 18, 2020
By Jihyun Kim
HONG KONG – South Korea’s AI-based biotech venture, Kaipharm Co. Ltd. has secured ₩5 billion (US$4.22 million) in series A funding. Founded in 2018, the firm has attracted a total of ₩7 billion in investments. Kaipharm will generate a reference dataset of 2,000 drugs (KMAP_2K) using next-generation sequencing (NGS). The dataset will include all the FDA-approved drugs to date.
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