Search results for "FDA approval"

GSK Wins Early FDA Approval for Oral Lung Cancer Drug Jideytro Following $10.6 Billion Nuvalent Acquisition

GSK Wins Early FDA Approval for Oral Lung Cancer Drug Jideytro Following $10.6 Billion Nuvalent Acquisition

A new oral therapy is now available for patients with ROS1-positive lung cancer whose disease has progressed following initial treatment or spread to...
K-Bio Targets Global Expansion: HK inno.N and HLB Seek FDA Approval

K-Bio Targets Global Expansion: HK inno.N and HLB Seek FDA Approval

South Korean pharmaceutical and biotech companies are aggressively pursuing product approvals and clinical trials with the U. S.
High Efficacy and Increased Convenience: The Three Obesity Drugs Awaiting FDA Approval

High Efficacy and Increased Convenience: The Three Obesity Drugs Awaiting FDA Approval

Since the World Health Organization recommended the use of obesity medications for adults last December, the market is...
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...
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...
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...