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BioWorld - Tuesday, April 7, 2026
Home » Topics » Regulatory » MOHW

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Kim Kyung-ah, CEO, Samsung Bioepis

South Korea to hike biosimilar approval fees, slash review times

Sep. 16, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s Ministry of Food and Drug Safety announced Sept. 12 plans to significantly raise drug application fees for biosimilars but slash their review times starting next year.
Read More
Kim Kyung-ah, CEO, Samsung Bioepis

South Korea to hike biosimilar approval fees, slash review times

Sep. 15, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s Ministry of Food and Drug Safety announced Sept. 12 plans to significantly raise drug application fees for biosimilars but slash their review times starting next year.
Read More
Spikevax vial and product packaging

South Korea clears Moderna’s Spikevax LP.8.1 vaccine for COVID-19

Sep. 2, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s Ministry of Food and Drug Safety approved Moderna Inc.’s Spikevax LP.8.1 vaccine as an updated shot for COVID-19 targeting the LP.8.1 variant, according to Moderna Korea’s announcement Sept. 1. The regulatory clearance comes days after the U.S. FDA accepted, on Aug. 27, Moderna’s supplemental BLAs for two of its COVID-19 vaccines, Spikevax and Mnexspike.
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K-Organoid Consortium

South Korea forms new organoid consortium for nonanimal testing

Aug. 26, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s Ministry of Food and Drug Safety (MFDS) launched a new industry-academia-research consortium to support the nation’s organoid industry, expected to grow in light of the U.S. FDA’s shift away from animal testing in the development of novel drugs.
Read More
Aivis

Aivis’ Qanti IHC uses AI to visualize biomarkers in cancer care

Aug. 25, 2025
By Marian (YoonJee) Chu
Lee Dae-hong founded Aivis Inc. in January 2021 as an AI-powered pathology software company, having led the development of the world’s first commercial under-display fingerprint recognition algorithm that was later incorporated into the Galaxy S10 and Galaxy A series of smartphones of Samsung Electronics Co. Ltd.
Read More
K-Organoid Consortium
Drug design, drug delivery & technologies

South Korea forms new organoid consortium for nonanimal testing

Aug. 21, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s Ministry of Food and Drug Safety (MFDS) launched a new industry-academia-research consortium to support the nation’s organoid industry, expected to grow in light of the U.S. FDA’s shift away from animal testing in the development of novel drugs.
Read More
K-Organoid Consortium

South Korea forms new organoid consortium for nonanimal testing

Aug. 21, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s Ministry of Food and Drug Safety (MFDS) launched a new industry-academia-research consortium to support the nation’s organoid industry, expected to grow in light of the U.S. FDA’s shift away from animal testing in the development of novel drugs.
Read More
COVID-19 mRNA vaccine vials, syringe

KDCA readies mRNA vaccines, tech for COVID-19, future outbreaks

Aug. 12, 2025
By Marian (YoonJee) Chu
No Comments
Korea Disease Control and Prevention Agency (KDCA) secured 5.3 million doses of COVID-19 vaccines made by Pfizer Inc./Biontech SE and Moderna Inc., officially including the mRNA-based vaccines in the country’s national immunization program on Aug. 5.
Read More
Tablets on conveyor belt

South Korea hits record $23B pharma production; 2024 exports up 28%

July 29, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s pharmaceutical manufacturing reached an all-time high of ₩32.86 trillion (US$23 billion) in 2024, representing a 7.3% increase from 2023 and the highest on record since the country began count in 1998.
Read More
Tablets on conveyor belt

South Korea hits record $23B pharma production; 2024 exports up 28%

July 24, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s pharmaceutical manufacturing reached an all-time high of ₩32.86 trillion (US$23 billion) in 2024, representing a 7.3% increase from 2023 and the highest on record since the country began count in 1998.
Read More
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