Search results for "FDA"

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 clearance from the U. S.
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...
Daewoong Pharmaceutical Cuts Off Hospital Sales After Domestic Nabota Vials Surface in the U.S.

Daewoong Pharmaceutical Cuts Off Hospital Sales After Domestic Nabota Vials Surface in the U.S.

Daewoong Pharmaceutical announced on July 23 that it has severed supply transactions with a domestic medical...
Celltrion Secures Historic FDA Interchangeability Status for Truxima

Celltrion Secures Historic FDA Interchangeability Status for Truxima

Celltrion announced on the 1st that the U.S. Food and Drug Administration has granted interchangeable status to Truxima...
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...
Idience Targeted Cancer Drug Candidate ‘Venadaparib’ Granted FDA Fast Track Designation

Idience Targeted Cancer Drug Candidate ‘Venadaparib’ Granted FDA Fast Track Designation

Idience, a novel anticancer drug developer under the Ildong Pharmaceutical Group, announced on the 18th that its...
Kyungbo Pharmaceutical Passes U.S. FDA On-Site Inspection at Asan Plant

Kyungbo Pharmaceutical Passes U.S. FDA On-Site Inspection at Asan Plant

Kyungbo Pharmaceutical announced on the 18th that it passed an on-site manufacturing inspection by the U. S.
FDA Approves Clinical Trial for Abl Bio’s Dual-Antibody ADC Candidate

FDA Approves Clinical Trial for Abl Bio’s Dual-Antibody ADC Candidate

Abl Bio announced on March 3rd that the U.S. Food and Drug Administration has approved the Investigational New Drug...
Onconic’s ‘Nesuparib’ Secures U.S. FDA Orphan Drug Designation for Small Cell Lung Cancer

Onconic’s ‘Nesuparib’ Secures U.S. FDA Orphan Drug Designation for Small Cell Lung Cancer

Onconic Therapeutics announced on the 24th that its novel anti-cancer candidate, 'Nesuparib', has been designated as an...