Binex, a Kosdaq-listed biopharmaceutical CDMO, has been subjected to a two-month suspension of sales operations for Bimo 5mg (ingredient: minoxidil), a hair loss treatment, for failing to submit necessary documents for the 2023 drug equivalence reevaluation.The product in question will not be availa
The Korean medical community is facing an unprecedented crisis as tensions escalate between the government and healthcare professionals over the proposed increase in medical school admissions by 2,000 in 2025.The dispute has broadened from trainee doctors to encompass the entire medical sector, with
i-SENS, a Kosdaq-listed biotech company, said it received product approval for CareSens Air, its continuous glucose monitoring (CGM) device, from the European Conformité Européenne (CE) Medical Device Regulation (MDR) last Thursday.The CareSens Air CGM system offers a non-invasive solution for diabe
Samjin Pharmaceutical announced a strategic investment of 1 billion won ($751,371) in Neurophet, a company specializing in AI solutions for brain disorder imaging, to fight dementia and stroke.Under the accord, the two companies seek to leverage Samjin’s extensive research resources, infrastructure,
Hugel said it received approval from the U.S. FDA for its botulinum toxin product, Letybo, in 50-unit and 100-unit dosages.This FDA approval marks a significant development for Hugel, following its third attempt to gain approval for Letybo.The company's journey to this point involved addressing feed
Celltrion said it reported consolidated sales of 2.1 trillion won ($1.5 billion) and operating income of 651 billion won in 2023, down 4.71 percent and up 0.66 percent, respectively, from the previous year.The company also posted a net profit of 539.2 billion won, down 0.53 percent, and an operating
Despite the government's ultimatum for disciplinary actions ending on Thursday, thousands of Korean medical residents have yet to return to work. As of Tuesday, a total of 9,267 residents from 100 training hospitals were ordered to return, with 5,976 confirmed to have not complied with the order.Vic
CHA Biotech said it had achieved its highest-ever annual revenue, posting a consolidated revenue of 954 billion won ($798 million) for the year 2023, up 13 percent from the previous year, thanks to strong business performance overseas.Despite the global economic slowdown, CHA Biotech attributed its
Kolon Life Science said it has decided to appeal to the Supreme Court against the revocation of the manufacturing and sales license for its knee osteoarthritis cell and gene therapy, Invossa-K Inj.This move comes after the company faced defeats in both the district and appellate courts.Most recently
Severance Hospital said that Professor Kuh Sung-uk at the Department of Neurosurgery, who also teaches at Yonsei University's College of Medicine, was honored with the grand prize at the 8th Medical Device Industry Awards Ceremony.Professor Kuh also serves as head of external relations at Severance
Celltrion said it has commenced the first shipment of Zymfentra, the world’s first subcutaneous form of infliximab, to the U.S. targeting autoimmune diseases. The company announced that the initial shipment batch was airlifted today to Atlanta, U.S., with plans to complete three shipment phases by e
In the rapidly evolving landscape of healthcare, digital therapeutics (DTx) have emerged as a groundbreaking third generation of treatment, drawing global attention as a promising sector. These software-based interventions, designed to treat diseases and enhance health much like traditional pharmace
Kakao Healthcare said over 50 health regulatory officials, including those from the Ministry of Food and Drug Safety, the WHO, and the U.S. FDA, visited its headquarters on Monday in light of the AI Regulatory and International Symposium 2024 (AIRIS 2024).The event is ongoing at the Shilla Seoul Hot
A Severance Hospital research team has revealed that a hemostatic powder made from plant extracts significantly improves the success rate of initial hemostasis in patients with gastrointestinal bleeding caused by peptic ulcers.Peptic ulcers, which result from the digestive acid eroding the lining of
CG Bio said it has become the largest shareholder in Innosys, a research and manufacturing company focused on orthopedic implants, following the completion of an equity acquisition on Tuesday.The acquisition involved CG Bio finalizing share transfer agreements for a 17.75 percent stake in Innosys an
A research team at CHA Bundang Medical Center has developed a promising solution for male infertility, particularly for patients suffering from Klinefelter syndrome.Klinefelter syndrome, characterized by the presence of an extra X chromosome (XXY instead of the typical XY), is the most common cause
Medytox has encountered a significant setback as the U.S. FDA has declined the biologics license application (BLA) for its innovative non-animal liquid botulinum toxin product, MT10109L, aimed at reducing moderate to severe glabellar (forehead) and lateral canthal (crow's feet) lines.The refusal, da
The Korean government has made a formal proposal to the nation's medical community, urging them to appoint representative members to engage in discussions on critical issues such as the expansion of medical school quotas and the cessation of ongoing collective actions, including strikes and mass res
Samsung Bioepis said that the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Pyzchiva, also known as SB17, a biosimilar candidate referencing Stelara, last Sunday. This biosimilar, referencing Janssen's Stelara (ingredient: uste
CKD Bio said it has confirmed the non-inferiority of CKDB-501A, aimed at improving moderate to severe frown lines, compared to Botox through a phase 3 clinical trial's topline results.The analysis of the data revealed that the improvement rate for frown lines when frowning was 80.69 percent (117 out