Search results for "U.S. clinical trial"

Placebo Outperforms TG-C: Data Errors and Stock Volatility Cloud Kolon TissueGene’s Phase 3 Trial

Placebo Outperforms TG-C: Data Errors and Stock Volatility Cloud Kolon TissueGene’s Phase 3 Trial

Kolon TissueGene’s knee osteoarthritis cell and gene therapy, TG-C, has failed to achieve statistical significance on its primary endpoints in its...
MediPost Begins Pivotal U.S. Phase 3 Trial for Regenerative Knee Therapy Cartistem

MediPost Begins Pivotal U.S. Phase 3 Trial for Regenerative Knee Therapy Cartistem

South Korean biotechnology company MediPost has entered full-scale Phase 3 clinical testing in the United States for its landmark knee osteoarthritis...
FDA Grants Streamlined Path for MediPost’s Cartistem, Slashing U.S. Trial Burden

FDA Grants Streamlined Path for MediPost’s Cartistem, Slashing U.S. Trial Burden

The U.S. Food and Drug Administration has agreed to a significantly streamlined clinical path for Cartistem, a landmark...
Can Daraxonrasib Reshape Pancreatic Cancer Care? Experts Weigh Promise and Limits

Can Daraxonrasib Reshape Pancreatic Cancer Care? Experts Weigh Promise and Limits

Pancreatic cancer remains one of the most formidable malignancies. Because early-stage disease rarely produces distinct...
Stopping Beta-Blockers After Heart Attack Safe for Stable Patients, Korea-France Study Finds

Stopping Beta-Blockers After Heart Attack Safe for Stable Patients, Korea-France Study Finds

One medication many patients take long-term following a heart attack is a beta-blocker.
Celltrion Files for South Korean Approval of Keytruda Biosimilar CT-P51

Celltrion Files for South Korean Approval of Keytruda Biosimilar CT-P51

Celltrion announced on August 24 that it has submitted a marketing authorization application to South Korea’s Ministry...
Hanmi Licenses Muscle-Preserving Obesity Drug Candidate to Genentech in $2.3 Billion Deal

Hanmi Licenses Muscle-Preserving Obesity Drug Candidate to Genentech in $2.3 Billion Deal

Hanmi Pharmaceutical has entered into an exclusive global licensing agreement with Genentech, a member of the Roche...
Taking Leqembi Isn’t Enough: Only 3% of Early Alzheimer’s Patients Follow Recommended Lifestyle Habits

Taking Leqembi Isn’t Enough: Only 3% of Early Alzheimer’s Patients Follow Recommended Lifestyle Habits

The arrival of disease-modifying treatments capable of slowing Alzheimer’s progression has offered patients newfound...
Moderna’s Landmark mRNA Cancer Vaccine Phase 3 Success Spotlights Korean Biotech Ties

Moderna’s Landmark mRNA Cancer Vaccine Phase 3 Success Spotlights Korean Biotech Ties

Positive late-stage clinical results for a personalized messenger RNA cancer vaccine developed by Moderna and Merck are...
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...