Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 14

Results For "regulatory"

1528 News Found

Pharma overhaul: EMA hails “Once-in-a-Generation” reform
Policy | December 16, 2025

Pharma overhaul: EMA hails “Once-in-a-Generation” reform

The reform is set to modernise how medicines are developed, authorised, and made available across the EU


Sobi to acquire Arthrosi Therapeutics in $950 million deal, bolstering gout pipeline
Clinical Trials | December 16, 2025

Sobi to acquire Arthrosi Therapeutics in $950 million deal, bolstering gout pipeline

The drug is currently being evaluated in two fully recruited global Phase 3 studies for progressive and tophaceous gout, with results expected in 2026.


Thermo Fisher Scientific appoints Anoopa Menon as Director
People | December 14, 2025

Thermo Fisher Scientific appoints Anoopa Menon as Director

In her previous roles, Menon led significant digital transformation efforts, implementing predictive analytics, automation


Biocon Biologics strikes deal to sell its version of the eye drug Aflibercept worldwide
News | December 14, 2025

Biocon Biologics strikes deal to sell its version of the eye drug Aflibercept worldwide

All pending litigation between Biocon Biologics, Regeneron, and Bayer will be dismissed


FDA completes inspection of SMS Pharma’s Vizag facility
Drug Approval | December 14, 2025

FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483


Lilly drug cuts risk of cancer progression, extends survival in advanced breast cancer trial
Clinical Trials | December 13, 2025

Lilly drug cuts risk of cancer progression, extends survival in advanced breast cancer trial

Updated results from the EMBER-3 study showed that the drug -- Inluriyo (imlunestrant) -- as a standalone treatment cut the risk of progression or death by 38%


Granules Life Sciences facility receives EIR from USFDA
News | December 12, 2025

Granules Life Sciences facility receives EIR from USFDA

This approval confirms the facility's compliance with FDA quality standards and regulatory requirements


GSK’s experimental lung cancer drug gains FDA orphan drug status
Drug Approval | December 12, 2025

GSK’s experimental lung cancer drug gains FDA orphan drug status

GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization