GC Green Cross MS Receives Approval for Dengue Virus Rapid Diagnostic Kit from Ministry of Food and Drug Safety
GC Green Cross MS Receives Approval for Dengue Virus Rapid Diagnostic Kit GENEDIA W Dengue NS1 Ag and GENEDIA W Dengue IgM/IgG Ab obtain export approval from Ministry of Food and Drug Safety SEOUL – GC Green Cross MS announced on the 18th that it has received export approval for its new diagnostic kit designed […]
Korean FDA Approves ‘Atralza’, a Competitor to ‘Dupixent’, for Atopic Dermatitis Treatment
‘Atralza’ Enters the Korean Market as a Promising Treatment for Atopic Dermatitis The Korean Food and Drug Administration has recently approved ‘Atralza’, a potential rival to ‘Dupixent’, for the treatment of atopic dermatitis. This breakthrough offers new hope to patients suffering from the condition. Newly Approved Drug for Atopic Dermatitis The Ministry of Food and […]
Rise in False and Exaggerated Advertisements for Menstrual Products Sparks Concern
False and Exaggerated Advertisements for Organic Sanitary Napkins Continue to Rise In recent years, there has been a significant increase in false and exaggerated advertisements promoting the benefits of organic sanitary napkins in relieving menstrual cramps. The Ministry of Food and Drug Safety (MFDS) has been monitoring this issue, yet the number of these deceptive […]
5th Korea-Japan Joint Pharmaceutical Symposium: Enhancing Collaboration and Regulatory Innovation in the Biopharmaceutical Industry
The Bio Pharmaceutical Society of Korea Announces the 5th Korea-Japan Joint Pharmaceutical Symposium In an effort to support the growth and collaboration of the biopharmaceutical industries in Korea and Japan, the Bio Pharmaceutical Society of Korea, led by Chairman Noh Yeon-hong, has announced the upcoming ‘5th Korea-Japan Joint Pharmaceutical Symposium’. The event, organized by both […]
Title: The Next Target? Speculations of Pharmaceutical Companies Facing Penalties Amidst Controversial ‘One-Hit-Out System’
Rumours Circulate in Pharmaceutical Industry as Companies Allegedly Attempt to Boost Sales In the wake of Korea Hutex Pharmaceuticals being flagged as the first company affected by the ‘one-strike-out system’, which rescinds a manufacturing plant’s suitability decision in the event of breaching pharmaceutical manufacturing and quality control (GMP) standards, speculation is rife regarding the next […]
Cell in Cells Receives Approval for Clinical Trial of Organoid Skin Regeneration Treatment
Cell in Cells Receives IND Approval for Organoid Skin Regeneration Treatment Jae-jin Cho, CEO of Cell in Cells, announced on the 16th that the company has obtained approval for its clinical trial plan (IND) from the Food and Drug Safety Administration. This approval is for their first pipeline, a new drug candidate called TRTP-101, which […]
Daewon Pharmaceutical Resumes Production of Chol Daewon Kids Pen Syrup After Ban Lifted
Daewon Pharmaceutical to Resume Manufacture and Sale of Chol Daewon Kids Pen Syrup Lifting of Ban Prompts Swift Action Daewon Pharmaceutical, under the leadership of CEO Baek Seung-yeol, has announced its intention to recommence the manufacture and sale of ‘Chol Daewon Kids Pen Syrup’. The decision comes in the wake of the Ministry of Food […]
Industry Speculation Surrounds Potential Scope of GMP Suitability Decision Cancellation for Korea Hutex Pharmaceuticals
Scope of Cancellation for GMP Suitability Decision on Hutex Pharmaceuticals Raises Industry Concerns There is growing anticipation within the industry regarding the scope of the cancellation of the first Good Manufacturing Practice (GMP) suitability decision for Korea Hutex Pharmaceuticals. The main question is whether the cancellation will apply to the entire large-scale dosage form or […]
Medtronic’s ‘DLP Pediatric One-Piece Artery Cannulae’ Designated as Urgently Needed Rare Medical Device for Cardiopulmonary Surgery
Medtronic’s ‘Vascular Tubes and Catheters for Cardiopulmonary Surgery’ Granted Urgently Needed Rare Medical Device Designation On the 31st, the Food and Drug Safety Administration designated four newly developed products by Medtronic as ‘urgently needed rare medical devices’. Among these products is the ‘DLP Pediatric One-Piece Artery Cannulae’, a crucial tool for cardiopulmonary surgery. Understanding the […]
Digital Tinnitus Treatment Device Begins Clinical Trial for FDA Approval
New Clinical Trials Approved for Medical Devices in July The Ministry of Food and Drug Safety has granted approval for 14 clinical trials of medical devices this month. Among these, 10 trials are confirmed as confirmatory clinical trials in order to obtain licenses for the devices. The approved trials include the development of skin cancer […]
