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BioWorld - Friday, April 10, 2026
Home » MFDS

Articles Tagged with ''MFDS''

Omniabio building

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

Jan. 15, 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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Globe showing Asia-Pacific region
Year in review

AI drives financings, approvals for APAC med-tech in 2024

Dec. 27, 2024
By Marian (YoonJee) Chu
AI pulled in major financings and approvals for Asia med-techs in 2024 as Asia Pacific countries played to individual strengths to maximize AI’s applications in the health care sector. While breakaway AI technologies like OpenAI’s ChatGPT reshaped and boosted many industries, AI also drove major financings for APAC med-techs weathering a wider macroeconomic downturn, with AI-based companies accounting for five out of 11 IPOs tracked on BioWorld’s med-tech IPOs list.
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Acryl

Acryl cleared as Korea’s first AI DTx to screen, diagnose depression

Dec. 23, 2024
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety cleared Acryl Inc.’s Acryl-D01 as the country’s first AI-based digital therapeutic software solution to aid depression screening and diagnosis on Dec. 20. Approved as a class II software as a medical device, Acryl-D01 utilizes a patient’s medical records to quantify and analyze the individual’s emotional response and assess the probability of having clinical depression based on the data.
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Celltrion wins Korea approvals of Prolia, Xgeva biosimilars

Nov. 26, 2024
By Marian (YoonJee) Chu
The Ministry of Food and Drug Safety (MFDS) approved South Korea’s first denosumab (Prolia/Xgeva) biosimilars, developed by Celltrion Inc. under the brand names of Stoboclo/Osenvelt (CT-P41) for respective indications, a move the company hopes will help secure first-mover advantage for the drugs, currently under review in the U.S. and Europe.
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Celltrion wins Korea approvals of Prolia, Xgeva biosimilars

Nov. 22, 2024
By Marian (YoonJee) Chu
The Ministry of Food and Drug Safety (MFDS) approved South Korea’s first denosumab (Prolia/Xgeva) biosimilars, developed by Celltrion Inc. under the brand names of Stoboclo/Osenvelt (CT-P41) for respective indications, a move the company hopes will help secure first-mover advantage for the drugs, currently under review in the U.S. and Europe.
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Novo Nordisk to launch Wegovy in South Korea mid-October

Oct. 7, 2024
By Marian (YoonJee) Chu
Danish pharma giant Novo Nordisk A/S is set to launch its blockbuster glucagon-like peptide-1 therapy, Wegovy (semaglutide), in South Korea’s growing obesity therapeutics market next week, a company official confirmed to BioWorld.
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Apimeds prices $11.5M IPO for bee venom-based therapy

Oct. 1, 2024
By Marian (YoonJee) Chu
Apimeds Pharmaceuticals US Inc., a subsidiary of Seoul, South Korea-based Inscobee Inc., is “counting down” to an official IPO on the New York Stock Exchange with its S-1 filing showing a targeted offering of $11.5 million.
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Apimeds prices $11.5M IPO for bee venom-based therapy

Sep. 30, 2024
By Marian (YoonJee) Chu
Apimeds Pharmaceuticals US Inc., a subsidiary of Seoul, South Korea-based Inscobee Inc., is “counting down” to an official IPO on the New York Stock Exchange with its S-1 filing showing a targeted offering of $11.5 million.
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Pharos PHI-101

Pharos Ibio wins MFDS orphan drug designation for AML drug

Sep. 10, 2024
By Marian (YoonJee) Chu
South Korean artificial intelligence-based drug developer Pharos Ibio Co. Ltd. said that the Ministry of Food and Drug Safety (MFDS) granted an orphan drug designation for PHI-101, a second-line therapy for acute myeloid leukemia (AML).
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Pharos PHI-101

Pharos Ibio wins MFDS orphan drug designation for AML drug

Sep. 5, 2024
By Marian (YoonJee) Chu
South Korean artificial intelligence-based drug developer Pharos Ibio Co. Ltd. said that the Ministry of Food and Drug Safety (MFDS) granted an orphan drug designation for PHI-101, a second-line therapy for acute myeloid leukemia (AML).
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