The Ministry of Food and Drug Safety (MFDS) said Friday that it published a guideline regarding the clinical pharmacological considerations for antibody-drug conjugate (ADCs) to help Korean companies enter early-stage clinical trials.ADCs have recently emerged as an essential platform for developing
The Fair Trade Commission (FTC) has decided to fine a total of 40.9 billion won ($32.2 million) on 32 companies, including GSK Korea, Yuhan Corp., GC, and SK discovery, for colluding in 170 vaccine tenders ordered by the Public Procurement Service for more than six years.One vaccine maker (GSK), six
The Ministry of Food and Drug Safety (MFDS) said on Thursday that it published three English guidelines related to digital therapeutics (DTx) and artificial intelligence (AI)-based medical devices.In particular, the documents include guidance on the review and approval of AI-based medical devices an
The Ministry of Food and Drug Safety (MFDS) has refuted criticism that patients suffer due to its hasty recall of an epilepsy drug.In a news release on Tuesday, the ministry said it was aware of the shortage of Sanofi's epilepsy and infantile spasms drug Sabril (vigabatrin) and would supply a large
The Ministry of Food and Drug Safety (MFDS) is taking administrative action against Korean pharmaceutical companies that advertised the generic drugs of Forxiga (dapagliflozin) as effective for chronic kidney failure and other effects than approved indications.According to ministry sources Wednesday
“Korea has become the capital of precocious puberty treatment,” the Health Insurance Review and Assessment Service (HIRA) said recently.The agency added that it plans to strengthen reimbursement management for precocious puberty treatment, pointing out that the popular misconception of related drugs
Starting in October, the government will reduce health insurance coverage for brain and cerebrovascular MRI examinations.The Ministry of Health and Welfare said Monday it has revised the notice on “details on the application standards and methods of benefits” to that effect. The revised notice will
Korea is seeing an increase in malaria cases again. Malaria is a vector-borne disease that is transmitted through mosquitoes. It is known as one of the infectious diseases with the highest global burden of disease, with approximately 247 million cases in 84 countries in 2021, according to the World
The Ministry of Food and Drug Safety (MFDS) said Friday that it has officially approved Paxlovid, Pfizer's oral Covid-19 treatment.Paxlovid had previously received emergency use approval (EUA) during the Covid-19 pandemic in December of 2021.However, the drug ministry granted full approval this time
The Ministry of Food and Drug Safety (MFDS) issued an administrative notice Friday that it would establish, revise and abolish 166 Korean Standards (KS) in the medical devices area and receive comments until Aug. 13.The notice is designed to improve the quality and safety of Korean medical devices a
The Ministry of Food and Drug Safety (MFDS) said Thursday that it will maintain the exsintguse standard for aspartame, amid ongoing controversy over its possible carcinogenic effects.The International Agency for Research on Cancer (IARC) and the Joint FAO/WHO Expert Committee on Food Additives (JECF
Experts pointed out once again on Wednesday that physician-assisted suicide could become an “inevitable option” instead of a “choice of last resort” for terminally ill patients to die with dignity.They argued that patients may be forced to choose doctor-aided suicide because it is easier and less ex
The Ministry of Health and Welfare has reportedly sent a letter requesting the withdrawal of an e-cigarette show to be held at an indoor venue.According to the health ministry, exhibition organizer The Fairs will hold the Korea Vape Show 2023 for three days at KINTEX in Goyang, Gyeonggi Province, fr
The Ministry of Health and Welfare has expressed concern over the National Health and Medical Workers’ Union’s announcement of a general strike on Thursday.Minister of Health and Welfare Cho Kyoo-hong held the second emergency inspection meeting on Tuesday to review emergency treatment plans and the
The Ministry of Health and Welfare has recognized Korean students graduating from 159 overseas medical schools in 38 countries as eligible to take the Korean Medical Licensing Examination (KMLE), data by a lawmaker showed. Graduates of these foreign medical schools still need to take and pass a sepa
Professor Jung Ki-suck, the former head of the National Advisory Committee on Infectious Diseases Crisis Response, will take over as President of the National Health Insurance Service (NHIS), a position that has been vacant for four months.NHIS is the operator of Korea's national health insurance pr
The government will build the Global Bio Campus, which will train bio-manufacturing workers in five areas for middle- and low-income countries.The five locations are Songdo (Incheon), Siheung (Gyeonggi Province), Osong (North Chungcheong Province), Hwasun (South Jeolla Province), and Andong (North G
Healing Paper CEO Hong Seung-il, who has operated the beauty and medical information platform Gangnam Unni, which shares plastic surgery reviews, was also sentenced to prison for violating the Medical Service Act at an appeals trial.On Thursday, the Seoul Central District Court’s Criminal Appeals Di
The Yoon Suk Yeol administration has announced its economic policy for the second half of this year, raising expectations about its role as pump-priming water for the bio industry’s recovery.On Tuesday, the government held the 18th Emergency Economic and Public Livelihood Council chaired by Presiden
A study conducted by the National Health Insurance Service (NHIS) showed that fourth booster doses of Pfizer and Moderna’s Covid-19 vaccines have little or no effect in preventing Covid-19 infections in people aged over 50 and older.Kim Jai-yong, Director of Big Data Research Division at the NHIS, s