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Results For "regulatory"

1624 News Found

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.


ImmunityBio scores first Asian approval for ANKTIVA in Macau
News | March 25, 2026

ImmunityBio scores first Asian approval for ANKTIVA in Macau

The Macau authorization followed a regulatory review that considered prior decisions by both the US FDA) and the European Medicines Agency


Novartis strikes $3 billion deal to acquire next-gen breast cancer drug
News | March 25, 2026

Novartis strikes $3 billion deal to acquire next-gen breast cancer drug

SNV4818, the oral drug, is pan-mutant–selective PI3K? inhibitor aimed at treating HR+/HER2- breast cancer and potentially other solid tumors


Pfizer and Valneva report promising Phase 3 Lyme disease vaccine results
Clinical Trials | March 24, 2026

Pfizer and Valneva report promising Phase 3 Lyme disease vaccine results

The company plans to submit the vaccine for regulatory review