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Results For "regulatory"

1838 News Found

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.


Anupam Rasayan to acquire 43.3%–48.2% equity stake in Bliss GVS Pharma
News | May 25, 2026

Anupam Rasayan to acquire 43.3%–48.2% equity stake in Bliss GVS Pharma

The acquisition marks Anupam Rasayan’s strategic entry into the pharmaceutical formulations segment


SMS Pharma posts 48% profit surge in FY26 as margins expand & portfolio shift drives growth
News | May 25, 2026

SMS Pharma posts 48% profit surge in FY26 as margins expand & portfolio shift drives growth

Revenue from operations climbed 13% to Rs. 886.87 crore


EU regulator backs Allergan Aesthetics’ Boey in key step toward approval
Drug Approval | May 25, 2026

EU regulator backs Allergan Aesthetics’ Boey in key step toward approval

The decision marks a key step in the centralized EU review process


Health ministry classifies Pregabalin under Schedule H1 to curb misuse
Policy | May 23, 2026

Health ministry classifies Pregabalin under Schedule H1 to curb misuse

New regulation mandates stricter prescription monitoring, sales record maintenance, and enhanced compliance across the pharmaceutical supply chain