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BioWorld - Thursday, July 24, 2025
Home » Topics » Regulatory » MOHW

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Approved stamp

South Korea approves record number of biosimilars in 2024

May 6, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.
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Approved stamp

South Korea approves record number of biosimilars in 2024

April 30, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.
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Sky Labs CART BP

Sky Labs seeks global expansion of world’s first BP monitor ring

April 22, 2025
By Marian (YoonJee) Chu
Sky Labs Inc. CEO and founder Jack Byunghwan Lee reported on plans to greatly expand the market for the company’s blood pressure monitor ring, including seeking regulatory approvals for the CART BP products in the U.S., Europe and Japan.
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Radiopharma AMC

Radiopharmaceuticals stake more territory in breast cancer care

April 8, 2025
By Marian (YoonJee) Chu
Radiopharmaceuticals, including 16α-18F-fluoro-17β-estradiol (18F-FES) PET/CT, are emerging as powerful tools with new diagnostic and therapeutic potential in breast cancer diagnosis and treatment, Han Sang-won, professor from the department of nuclear medicine at Asan Medical Center, recently told BioWorld.
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South Korea clears world’s first recombinant anthrax vaccine

April 8, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety on April 8 cleared Barythrax injection (GC-1109) as the world’s first recombinant anthrax vaccine. The product was codeveloped by GC Biopharma Corp. and Korea Disease Control and Prevention Agency.
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Radiopharma AMC

Radiopharmaceuticals stake more territory in breast cancer care

April 4, 2025
By Marian (YoonJee) Chu
Radiopharmaceuticals, including 16α-18F-fluoro-17β-estradiol (18F-FES) PET/CT, are emerging as powerful tools with new diagnostic and therapeutic potential in breast cancer diagnosis and treatment, Han Sang-won, professor from the department of nuclear medicine at Asan Medical Center, recently told BioWorld.
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KIMES 2025
KIMES 2025

Trio of neuro disease-focused firms highlighted at KIMES 2025

March 25, 2025
By Marian (YoonJee) Chu
At the four-day KIMES 2025 exhibition, more than 35,000 products and prototypes were on display. In the clamor, BioWorld engaged with three promising neurological disease-focused companies – Readycure Inc., Neurive Co. Ltd. and Vuno Inc. – that showcased innovative technology for conditions like Alzheimer’s disease and tinnitus at the Seoul-based event.
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Ribbons of digital data

South Korea issues world’s first generative AI medical device guideline

Feb. 4, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety said it released the world’s first guideline on reviewing and approving generative artificial intelligence-based medical devices Jan. 24, to help establish standards on the technology’s applications in the medical field.
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Ribbons of digital data

South Korea issues world’s first generative AI medical device guideline

Jan. 24, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety said it released the world’s first guideline on reviewing and approving generative artificial intelligence-based medical devices Jan. 24, to help establish standards on the technology’s applications in the medical field.
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Omniabio building

Medipost grows US, Canada base; plans US phase III of Cartistem

Jan. 21, 2025
By Marian (YoonJee) Chu
As more Asia biotechs turn to regenerative medicine to address disorders without a cure, Medipost Inc. is continuing global expansion with Cartistem, its allogeneic human umbilical cord blood-derived mesenchymal stem cell product that gained clearance in South Korea in 2012 to treat knee osteoarthritis.
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