Tuesday, August 4, 2026

North Korean Defector Kim Ryon-hee Appeals for Return Home: What’s Next in Her 6-Year Legal Battle?

North Korean defector Kim Ryeon-hee pleads for repatriation, asserting it's a personal choice, not an attack on South Korea.

Dong-A University Hospital Launches AI-Driven thynC Monitoring System

Dong-A University Hospital launches AI-powered smart bed system thynC, enhancing patient monitoring and safety across general wards.

South Korea–Canada 2+2 in Ottawa: Can Defense Industry Ties and Submarine Cooperation Go Next Level?

South Korea's Foreign Minister Cho Hyun emphasizes strategic cooperation with Canada during discussions on defense and technology partnerships.

Tag: FDA

CG Bio Treats First U.S. Patient With Bone Graft Substitute, Advances FDA Approval

Sigibio accelerates clinical development for FDA approval after the first U.S. patient procedure with its next-gen bone substitute, Novosis Putty.

HLB PEP Achieves FDA Registration for Vasopressin API: What This Means for Global Markets

HLB PEP has registered Vasopressin API with the FDA, aiming for global market entry and expanding its peptide portfolio.

EuBiologics Registers EcML Adjuvant Platform With U.S. FDA Drug Master File

EuBiologics' EcML™ vaccine adjuvant platform has been registered with the FDA, enhancing immunogenicity and enabling global collaborations.

Eli Lilly’s Retatrutide: The Revolutionary Triple Hormone Treatment for Obesity – What You Need to Know

Eli Lilly's retatrutide shows promising results in Phase 3 trials, aiming for FDA approval for obesity and related conditions in 2027.

Kolon Group’s Biotech Bet Faces Uncertainty as October Trial Readout Becomes Critical

Kolon TissueGene's TG-C osteoarthritis treatment failed its first U.S. Phase 3 trial, raising doubts about the biotech's future.

How Celltrion’s Truxima Dominates the U.S. Rituximab Market: A 4-Month Winning Streak

Celltrion's Truxima leads the U.S. rituximab market for four months, gaining FDA interchangeability status, boosting growth prospects.

HLB’s Rivoceranib Drug Approval: What the FDA’s VAI Classification Means for Liver Cancer Treatment

HLB's Rivoceranib facility received a VAI classification from the FDA, indicating compliance with GMP standards, aiding drug approval progress.

HLB’s Liver Cancer Drug: FDA’s VAI Conclusion Sparks Hope for Approval

HLB's Rivoceranib facility passed FDA inspection, receiving VAI classification, moving towards new liver cancer drug approval.

Penetrium’s Innovative Cancer Drug Enters Phase 2 Trials in the U.S.: What You Need to Know

Penetrium Bioscience is submitting an IND for Penetrium to start Phase 2 cancer trials in the U.S., leveraging prior safety data.

[Exclusive] HLB’s Liver Cancer Drug Clears Camrelizumab CMC Review, but Hengrui Manufacturing Facility Becomes New Hurdle

HLB's liver cancer drug approval faces delays due to FDA findings at Hengrui's facility, despite resolution of previous issues.

ABL Bio to Launch Global Phase 3 Trial of ABL111 in December, Targeting First-Line Gastric Cancer Treatment

ABL Bio will begin global Phase 3 trials for its dual antibody gastric cancer treatment 'ABL111' this December after FDA discussions.

L&K Biomed’s BlueX-C: First Clinical Success in the U.S. Spine Implant Market!

L&K Biomed's BlueX-C cervical cage achieves FDA approval and successful clinical application, signaling strong market potential in the U.S.

Celltrion’s Truxima becomes first rituximab biosimilar in U.S. to receive interchangeability designation

Celltrion's Truxima gains FDA interchangeability status, enhancing its market position and credibility in blood cancer treatment.

Seers wins FDA clearance for wearable ECG device, accelerating U.S. expansion

Seers' mobiCARE™ ECG monitor received FDA clearance, accelerating U.S. market entry and enhancing global expansion plans.

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