FDA Clears Trial for Next-Gen CAR-T Therapy That Creates Cancer-Fighting Cells Inside Patients
CAR-T therapy for blood cancers conventionally involves removing a patient’s immune cells, modifying them in a laboratory to attack cancer cells, and...
Search results for "FDA"
FDA Approves Celltrion’s Avtozma for Pediatric COVID-19 in High-Risk Patients
Celltrion announced on October 7 that the U.S. Food and Drug Administration has approved an expanded pediatric indication for the intravenous...
Global Tobacco Giants Push Nicotine Pouches After FDA Authorizes Reduced-Risk Claims
Multinational tobacco corporations dominating the global market are rapidly shifting focus toward non-combustible...
FDA Approves Emcitate as First Treatment for Rare Genetic Disorder That Starves Brain of Thyroid Hormone
Thyroid hormone is essential for infant brain development. But when the cellular "gateway" that transports the hormone...
New Parkinson’s Drug Cuts Daily “Off” Time by Nearly an Hour for Patients on Levodopa
You take your medication, but before long, stiffness returns and your hands begin to tremble.
Celltrion Files Phase 4 IND with FDA to Support 240 mg High-Dose Zymfentra Regimen in US
Celltrion has submitted an Investigational New Drug application to the U.S. Food and Drug Administration for a Phase 4...
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
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
Zamenix, a kidney stone surgery robot developed by medical robotics company Roen Surgical, has received Class II...
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...