Fast-Tracking Biosimilars: South Korea to Waive Phase 3 Clinical Trials Under New Guidelines
South Korean regulators have revised requirements to significantly reduce the time and financial burden of biosimilar development.
Search results for "product approval"
Medytox’s Neuramis Clinches China Approval, Paving Way for Dermal Filler Market Entry
Medytox announced on the 25th that China’s National Medical Products Administration has granted product approval for its hyaluronic acid dermal...
FDA Approves Celltrion’s Avtozma for Pediatric COVID-19 in High-Risk Patients
Celltrion announced on October 7 that the U.S. Food and Drug Administration has approved an expanded pediatric...
Global Tobacco Giants Push Nicotine Pouches After FDA Authorizes Reduced-Risk Claims
Multinational tobacco corporations dominating the global market are rapidly shifting focus toward non-combustible...
Early Flu Outbreak Shifts Demand to Ibuprofen-Based Cold Remedies as Hanmi Leads Market
With wide daily temperature fluctuations causing seasonal influenza to spread nearly a month earlier than usual in...
Beyond Cosmetics: Foreign Tourists Stock Up on Korean OTC Skin Ointments
Search TikTok for "must-buy items at Korean pharmacies," and a steady stream of video recommendations fills the screen.
GC Pharma’s Homegrown mRNA Vaccine Advances to Phase 2 Trials
GC Pharma announced on the 11th that South Korea’s Ministry of Food and Drug Safety has approved its Phase 2 clinical...
South Korea to Ban ‘AI Fake Doctors’ in Medical Device Ads Starting December
Starting this December, advertisements that use artificial intelligence to generate virtual figures resembling real...
Yuhan Corp. Launches Drinkable Joint Supplement 'Yuhan Chondroitin 1200'
Yuhan Corp. announced on Aug. 31 that it will launch "Yuhan Chondroitin 1200," a liquid joint and cartilage health...
Beyond FDA Clearance: 'MedTech Insight 2026' Navigates U.S. Hospital Procurement and Global Market Access
Securing regulatory clearance for a medical device in overseas markets is a major milestone, but it does not guarantee...