Celltrion receives U.S. FDA approval for EYDENZELT, biosimilar referencing EYLEA

Celltrion plans to enter the U.S. ophthalmology market to meet diverse needs of patients suffering from various eye conditions [Press Release] Celltrion announced on October 9 that the U.S. Food and Drug Administration (FDA) has approved EYDENZELT (aflibercept-boav), biosimilar referencing EYLEA (aflibercept), for the treatment of neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR). Aflibercept is a VEGF inhibitor formulated as an injection for the eye that blocks the growth of new blood vessels and de

FDA approves expanded pediatric indications for YUFLYMA and unbranded adalimumab-aaty in the United States

[Press Release] Celltrion announced on October 17 that the U.S. Food and Drug Administration (FDA) has approved expanded indications for YUFLYMA (adalimumab-aaty) and its unbranded version, to include the treatment of hidradenitis suppurativa (HS) in adolescent patients aged 12 years and older, and uveitis (UV) in pediatric patients aged 2 years and older. The FDA previously approved YUFLYMA as a biosimilar to Humira for a variety of indications, including rheumatoid arthritis (RA), psoriatic ar

Hanmi's Next-Gen EZH1/2 Dual Inhibitor Demonstrates Safety and Anti-tumor Activity in Phase I Study

Partial Response and Durable Stable Disease Observed in Patients, Supporting Further Clinical Development [Press Release] On October 22, Hanmi announced that its investigational targeted anticancer therapy, HM97662, a novel EZH1/2 dual inhibitor, demonstrated a favorable safety profile and encouraging early antitumor activity in a first-in-human Phase 1 study, marking a meaningful step forward in its global clinical development. Hanmi Pharmaceutical participated in the European Society for Medical Oncology (ESMO) Congress 2025, held in Berlin, Germany, from October 17 to 21, where the company presen

Boryung Successfully Concludes 2025 Humans In Space Youth Final Competition

Winners to have artwork presented on ISS and visit U.S. space agencies [Press Release] On October 21, Boryung announced that it successfully concluded the final round of the '2nd Humans In Space Youth (HIS Youth)' competition on the 18th at Yonsei University's Future Education Center. HIS Youth is an educational program launched by Boryung to nurture the next generation of space life science talent. This marks the second edition of the competition, following its inaugural event last year. This year's competition was held for elementary, middle, and high school stud

"Avantor Commits to Supporting Next-Generation Bio Ecosystem Across Asia"

[Interview] Avantor Benoit Gourdier EVP, Bioscience Production South Korea Leads Evolution of Bio Industry…Seeking Active Opportunities for Technological Cooperation in Cell & Gene Therapies and Next-Generation Biopharmaceuticals [관련기사="한국, 바이오 산업의 진화 선도…아반토, 아시아 전역의 차세대 바이오 생태계 지원에 전념할 것"] Avantor Benoit Gourdier EVP, Bioscience Production. [MedigateNews] Founded in 1904, Avantor is a global life sciences company supplying essential products and services to customers in the life sciences and advanced technology industries. Recently, Avantor established an

Hanmi’s Next-Generation EZH1/2 Dual Inhibitor Demonstrates Potential to Overcome Resistance Mechanisms

HM97662 Exhibits Superior Antitumor Activity Compared to EZH2-Selective Inhibitor Tazemetostat Dr. Young Su Noh (center), Director of Hanmi’s Oncology Clinical Team, presents the latest research findings on HM97662 to attendees, including Dr. Franco Cavalli (fourth from left), and president of the ICML, at the International Conference on Malignant Lymphoma (ICML 2025) held in Lugano, Switzerland. [Press Release] Hanmi Pharmaceutical’s next-generation targeted anticancer therapy, the EZH1/2 dual inhibitor HM97662, has drawn significant attention from global lymphoma experts following precl

Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA

STEQEYMA now matches all dosage forms and strengths of its reference product, STELARA [Press Release] On June 15, Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), in a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection. The additional presentation is approved for the treatment of pediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis (PsO) or psoriatic arthritis (PsA).[1] With this approval, STEQEYMA now offe

Daewoong Pharmaceutical and Salipro Biotech, Collaboration Agreement to Advance Development of Novel Therapeutics

[Press Release] On June 11, Swedish biotech company Salipro Biotech AB announced that it has entered into a research collaboration with Daewoong Pharmaceutical. Daewoong Pharmaceutical gains access to Salipro Biotech’s expertise and Salipro® platform for stabilizing challenging membrane proteins (e.g., GPCRs, ion channels, transporters). The collaboration will target a specific membrane protein to aid Daewoong’s development of novel small molecule drugs. Under the terms of this agreement, the co

“Uncertain international circumstances and enlightened self-interest help prevent greater losses.”

[Interview] Joon Oh, Chairman of Save the Children “The ones suffering from the political conflict are the patients… Hope the government and the medical community resolve this through dialogue.” [관련 기사=세이브더칠드런 오준 이사장 “불확실한 국제 정세, 계몽된 자기 이익이 더 큰 손실 막는다”] Save the Children Korea Chairman, Joon Oh [MedigateNews] Amid rising political uncertainty in international affairs and a deepening global economic downturn, Save the Children Korea Chairman, Joon Oh, emphasized the importance of “enlightened self-interest.” He stated, “The term ‘enlightened self

Lunit Study in Radiology Highlights Trust Gap Between Radiologists and AI in Breast Cancer Screening

Despite strong performance from AI, fewer recalls from AI-flagged cases point to challenges in human-AI collaboration [Press Release] SEOUL, South Korea, April 9, 2025-- Lunit(루닛), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced the publication of a new study in Radiology (RSNA's flagship journal), highlighting how radiologists interact with AI in real-world breast cancer screening. Lunit’s AI identified more cancers, but radiologists recalled