Search results for "FDA approval"

Beyond FDA Clearance: 'MedTech Insight 2026' Navigates U.S. Hospital Procurement and Global Market Access

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 supply contracts with foreign...
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 symptoms, many cases have...
Roen Surgical’s Kidney Stone Robot Zamenix Secures US FDA Clearance

Roen Surgical’s Kidney Stone Robot Zamenix Secures US FDA Clearance

Zamenix, a kidney stone surgery robot developed by medical robotics company Roen Surgical, has received Class II...
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...
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...
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...
Shifting the Burden: Why South Korea’s OB-GYNs Reject 'Discretion' on Abortion Pills

Shifting the Burden: Why South Korea’s OB-GYNs Reject 'Discretion' on Abortion Pills

The South Korean government's proposal to leave the prescription of abortion medication up to the professional...
Anchoring the U.S. Supply Chain: GC Green Cross Expands 30-Year Cytiva Partnership to Secure Alyglo Production

Anchoring the U.S. Supply Chain: GC Green Cross Expands 30-Year Cytiva Partnership to Secure Alyglo Production

GC Green Cross has secured priority access to critical manufacturing consumables to stabilize the production of Alyglo,...
Daewoong Pharmaceutical’s Nabota Hits 1 Trillion Won in Cumulative Sales 12 Years Post-Launch

Daewoong Pharmaceutical’s Nabota Hits 1 Trillion Won in Cumulative Sales 12 Years Post-Launch

Daewoong Pharmaceutical announced on the 13th that its flagship botulinum toxin product, Nabota, surpassed 1 trillion...
ABL Bio’s Stomach Cancer Drug Shows Promise in Once 'Untreatable' Patients

ABL Bio’s Stomach Cancer Drug Shows Promise in Once 'Untreatable' Patients

South Korean platform biotech company ABL Bio announced that development remains firmly on track despite investor...