Search results for "Ministry of Food and Drug Safety"

JW Pharmaceutical Files for Phase 3 Trial of Biweekly Obesity Drug Bofanglutide

JW Pharmaceutical Files for Phase 3 Trial of Biweekly Obesity Drug Bofanglutide

JW Pharmaceutical announced on Aug. 18 that it has submitted an Investigational New Drug application to South Korea’s Ministry of Food and Drug...
Chong Kun Dang’s CKD-339 Enters Phase 3 in South Korea for Patients Uncontrolled on Monotherapy

Chong Kun Dang’s CKD-339 Enters Phase 3 in South Korea for Patients Uncontrolled on Monotherapy

CKD-339, an essential hypertension treatment under development by Chong Kun Dang, is advancing into a Phase 3 clinical trial in South Korea.
Fast-Tracking Biosimilars: South Korea to Waive Phase 3 Clinical Trials Under New Guidelines

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...
Combination Therapy: Laennec Achieves Pain Relief with One-Fifth the Steroid Dose in Preclinical Study

Combination Therapy: Laennec Achieves Pain Relief with One-Fifth the Steroid Dose in Preclinical Study

An animal study has revealed that combining GC Green Cross Wellbeing’s human placental hydrolysate treatment, Laennec...
Hanmi Pharmaceutical’s Paltan Smart Plant Cuts Drug Stockouts 57% Following Reorganization

Hanmi Pharmaceutical’s Paltan Smart Plant Cuts Drug Stockouts 57% Following Reorganization

Stockout cases have dropped sharply at Hanmi Pharmaceutical’s primary manufacturing base for synthetic drugs.
Courier-Delivered ‘Baekok Shots’ Were Actually Intended for Neurological Disorders

Courier-Delivered ‘Baekok Shots’ Were Actually Intended for Neurological Disorders

Some consumers have been purchasing prescription-only injectable drugs online without a doctor’s oversight.
550 Days in Limbo: Groups Demand 100-Day Fast-Track Insurance Coverage for Breakthrough PAH Drug Winrevair

550 Days in Limbo: Groups Demand 100-Day Fast-Track Insurance Coverage for Breakthrough PAH Drug Winrevair

With national health insurance coverage for the new pulmonary arterial hypertension treatment Winrevair (active...
Samsung Bioepis Seeks South Korean Approval for Keytruda Biosimilar SB27

Samsung Bioepis Seeks South Korean Approval for Keytruda Biosimilar SB27

Samsung Bioepis announced on Aug. 10 that it has submitted a marketing authorization application to South Korea's...
From Retinal Scans to Brain Imaging: South Korea Backs Six Medical AI Tools for Fast-Track Hospital Adoption

From Retinal Scans to Brain Imaging: South Korea Backs Six Medical AI Tools for Fast-Track Hospital Adoption

Medical AI tools designed to assess cardiovascular risk from retinal images and analyze brain scans for stroke severity...
White Frost on Ice Cream: Safe to Eat or Time to Toss?

White Frost on Ice Cream: Safe to Eat or Time to Toss?

On a hot summer day, a freezer stocked with ice cream is a welcome comfort. Many people, particularly when eating from...