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Results For "regulatory"

1275 News Found

Dipharma receives regulatory authorization for the new line at Its cGMP pilot plant
Drug Approval | October 09, 2022

Dipharma receives regulatory authorization for the new line at Its cGMP pilot plant

The company increases its efficiency and is able to face the growing demand for its services.


Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022
Drug Approval | August 20, 2022

Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022

Therapy recently approved in Canada under the brand name KORSUVA


Navidea Biopharmaceuticals gets regulatory approval of Lymphoaim in India
News | April 19, 2022

Navidea Biopharmaceuticals gets regulatory approval of Lymphoaim in India

Tc99m tilmanocept is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer


Dysval gets regulatory approval in Japan
Drug Approval | March 29, 2022

Dysval gets regulatory approval in Japan

Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients


Guardant Health receives regulatory approval for Guardant360 CDx in Japan
Medical Device | March 14, 2022

Guardant Health receives regulatory approval for Guardant360 CDx in Japan

Guardant360 CDx is a comprehensive genomic profiling test that utilizes blood samples from patients with advanced solid cancers


Sanofi and GSK to seek regulatory authorization for Covid-19 vaccine
News | February 24, 2022

Sanofi and GSK to seek regulatory authorization for Covid-19 vaccine

100% efficacy against severe Covid-19 disease and hospitalizations


Top five pharma looks to LifeSphere IDMP for regulatory readiness
News | February 18, 2022

Top five pharma looks to LifeSphere IDMP for regulatory readiness

ArisGlobal's industry-leading regulatory software chosen by top pharmaceutical company for IDMP preparation and global readiness


Nirsevimab EMA regulatory submission accepted under accelerated assessment
Biotech | February 17, 2022

Nirsevimab EMA regulatory submission accepted under accelerated assessment

Nirsevimab is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial virus season with a single dose


Need for integration of various regulatory agencies : Pharma secretary
News | March 26, 2021

Need for integration of various regulatory agencies : Pharma secretary

Integration of various regulatory agencies with a single-window system and putting in place a transparent, stable, predictable and easy to navigate interface.