Search results for "product approval"

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 development.
Medytox’s Neuramis Clinches China Approval, Paving Way for Dermal Filler Market Entry

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...
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...
A Third Arm for Therapists: The Surgeon Bringing ‘Self-Driving’ Tech to Physical Rehab

A Third Arm for Therapists: The Surgeon Bringing ‘Self-Driving’ Tech to Physical Rehab

Artificial intelligence may be able to detect a patient’s disease, but it cannot move stiff arms and legs for them.
VOYXACT Preserves Kidney Function for Two Years in Phase 3 IgA Nephropathy Trial

VOYXACT Preserves Kidney Function for Two Years in Phase 3 IgA Nephropathy Trial

Otsuka Pharmaceutical’s VOYXACT (active ingredient: sibeprenlimab) demonstrated long-term kidney protection by...
Alteogen Signs $365 Million Licensing Deal for Subcutaneous Drug Delivery Platform ALT-B4

Alteogen Signs $365 Million Licensing Deal for Subcutaneous Drug Delivery Platform ALT-B4

Biotechnology firm Alteogen has signed an exclusive technology-transfer agreement worth up to $365 million...
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...
HK inno.N's K-CAB Secures Sixth Indication to Prevent Ulcers from Long-Term NSAID Use

HK inno.N's K-CAB Secures Sixth Indication to Prevent Ulcers from Long-Term NSAID Use

HK inno.N’s gastroesophageal reflux disease drug K-CAB has expanded its approved uses to include the prevention of...
Forget Wegovy and Mounjaro: How Hanmi’s 'EPPE' Is Redefining Obesity Care

Forget Wegovy and Mounjaro: How Hanmi’s 'EPPE' Is Redefining Obesity Care

Hanmi Pharmaceutical has officially named its in-development obesity treatment "EPPE.
Daewoong Pharmaceutical’s Nabota Enters Kuwait, Expanding Middle East Footprint to Seven Countries

Daewoong Pharmaceutical’s Nabota Enters Kuwait, Expanding Middle East Footprint to Seven Countries

Daewoong Pharmaceutical’s botulinum toxin product Nabota has entered Kuwait, expanding its Middle East footprint to...