- Opinion
- [Reporter's View] Approval-to-reimbursement takes only 6 mth
- by Lee, Hye-Kyung Sep 8, 2025 06:15am
- The Ministry of Food and Drug Safety (MFDS) has been operating the 'Global Innovative products on Fast Track (GIFT)' since 2022. GIFT is a 'Program Supporting the Expedited Review of Global Innovative Products' launched by the MFDS, aiming to quickly launch medicines for life-threatening diseases, such as cancer, and rare diseases, as well a
- Policy
- Savings of KRW 32.6B expected from 2025 'Type-Da' PVA nego
- by Lee, Tak-Sun Sep 5, 2025 06:20am
- The National Health Insurance expenditure is expected to see a savings effect of approximately KRW 32.6 billion due to this year's negotiation for the 'Type-Da' Price-Volume Agreement. This year's negotiated items total 110, comprising 48 active ingredients. The ceiling price of these items has been adjusted as of September 1. Items subjec
- Company
- Zynyz receives orphan drug designation in Korea
- by Eo, Yun-Ho Sep 5, 2025 06:20am
- The immuno-oncology drug Zynyz that Handok has decided to market in Korea has been designated as an orphan drug in Korea. The Ministry of Food and Drug Safety (MFDS) recently announced the designation through a public notice. Specifically, the drug is indicated for ▲Merkel cell carcinoma and ▲ squamous cell carcinoma of the anal canal (SCAC
- Company
- MenQuadfi’s indication includes infants as young as 6 weeks
- by Hwang, byoung woo Sep 5, 2025 06:19am
- On the 4th, Sanofi Kore announced that its fully liquid quadrivalent meningococcal vaccine, MenQuadfi, received expanded indication approval from the Ministry of Food and Drug Safety (MFDS) on August 26. The new approval allows MenQuadfi’s vaccination for infants from 6 weeks to under 2 years of age. With the indication extension, MenQua
- Company
- HK Inno.N and Pfizer partner to distribute COVID-19 vaccine
- by Lee, Seok-Jun Sep 5, 2025 06:18am
- HK inno.N (CEO Dal-Won Kwak) announced on the 4th that it has signed a co-promotion agreement with Pfizer Korea (CEO Dong-Wook Oh) for the 2025&8211;2026 season distribution of the new COVID-19 variant vaccine, Comirnaty LP.8.1 Prefilled Syringe (SARS-CoV-2 mRNA Vaccine), as part of the National Immunization Program (NIP). Last year, H
- Company
- Fruzaqla may be prescribed at general hospitals in KOR
- by Eo, Yun-Ho Sep 4, 2025 06:12am
- ] The new colon cancer drug Fruzaqla is may now be prescribed at general hospitals in Korea. According to industry sources, Fruzaqla (fruquintinib), a colorectal cancer therapy from Takeda Korea that selectively inhibits vascular endothelial growth factor receptors (VEGFR)-1, 2, and 3, has passed the drug committees (DC) of 41 major medica
- Product
- Generic substitutions and INN-based prescriptions on track
- by Kim JiEun Sep 4, 2025 06:12am
- The prolonged instability in drug supply has fueled momentum in the pharmacy community, with both streamlined generic substitutions and limited mandatory international nonproprietary name prescriptions gaining traction in the National Assembly. On September 2, Democratic Party of Korea lawmaker Jong-Tae Jang introduced amendments to the M
- Policy
- Pilot Drug Approval·Review Coordination Committee extended
- by Lee, Hye-Kyung Sep 4, 2025 06:10am
- The pilot operation period for the Pharmaceutical Approval and Review Coordination Committee will be extended by one year. According to the pharmaceutical industry on September 3, the Ministry of Food and Drug Safety (MFDS) decided to extend the pilot period for the Coordination Committee by one year, starting from August 29. The committee ha
- Policy
- MFDS allocates KRW 812.2 billion for next year's budget plan
- by Lee, Hye-Kyung Sep 4, 2025 06:09am
- The Ministry of Food and Drug Safety (MFDS; Minister, Yu-Kyoung Oh) has announced that its budget for 2026 has been set at a total of KRW 812.2 billion, an increase of KRW 63.3 billion (8.4%) from this year's budget of KRW 748.9 billion. This budget plan was focused on facilitating the smooth execution of the new government's national ta
- Company
- Novo Nordisk, Kakao Health sign digital healthcare MOU
- by Cha, Jihyun Sep 4, 2025 06:09am
- Kakao Healthcare (CEO Hee Hwang) announced on the 3rd that it has signed a memorandum of understanding with the multinational pharmaceutical company, Novo Nordisk Korea (General Manager Kasper Roseeuw Poulsen) to build a digital healthcare ecosystem for obesity and diabetes patients. The signing ceremony, held on September 2 at Novo Nordisk K
