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Results For "regulatory"

1215 News Found

Briefs: Hikal and Sun Pharma
Drug Approval | June 17, 2025

Briefs: Hikal and Sun Pharma

Sun Pharma gets 8 observations from USFDA for Halol facility


USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru
Drug Approval | June 17, 2025

USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru

The inspection concluded successfully, with the facility found to be in compliance with the required regulations


Novo Nordisk to advance subcutaneous and oral amycretin for weight management into phase 3 clinical development
News | June 16, 2025

Novo Nordisk to advance subcutaneous and oral amycretin for weight management into phase 3 clinical development

The decision to advance subcutaneous and oral amycretin into phase 3 is based on feedback received from regulatory authorities


Sigachi Industries gets ToR approval for API and specialty chemicals manufacturing facility in Andhra Pradesh
News | June 13, 2025

Sigachi Industries gets ToR approval for API and specialty chemicals manufacturing facility in Andhra Pradesh

The project will be instrumental in enhancing the company's API manufacturing capacity and global reach


Aayush Wellness to form subsidiary in Singapore to drive Southeast Asia expansion
News | June 12, 2025

Aayush Wellness to form subsidiary in Singapore to drive Southeast Asia expansion

This strategic expansion marks a significant step in the company's global growth strategy


Carbogen Amcis enters into a co-investment agreement of CHF 25+ million to expand Swiss sites
News | June 09, 2025

Carbogen Amcis enters into a co-investment agreement of CHF 25+ million to expand Swiss sites

This project builds on a previous joint funding agreement between CARBOGEN AMCIS and the same customer in April 2021


AstraZeneca’s fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia
News | June 07, 2025

AstraZeneca’s fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia

AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for Calquence combinations


NPPA fixes retail prices for 41 drug combinations
Policy | June 06, 2025

NPPA fixes retail prices for 41 drug combinations

The NPPA has capped prices for 41 drug combinations including diabetes, cholesterol, and sleep disorder treatments