Search results for "FDA"

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 institution after discovering two vials...
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 (active ingredient:...
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...
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...
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...
HK Innoen's 'K-Cab' Applies for New Drug Approval from the U.S. FDA

HK Innoen's 'K-Cab' Applies for New Drug Approval from the U.S. FDA

HK Innoen announced on the 13th that its U.S. partner, Sevela Pharmaceuticals, a subsidiary and specialist in...