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Results For "regulatory-authority"

61 News Found

Wockhardt files marketing authorisation application for WCK 5222 with EMA
News | January 08, 2026

Wockhardt files marketing authorisation application for WCK 5222 with EMA

WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation


EMA grants orphan drug status to Sanofi’s Efdoralprin Alfa for rare lung disease
Drug Approval | December 20, 2025

EMA grants orphan drug status to Sanofi’s Efdoralprin Alfa for rare lung disease

Efdoralprin alfa, a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, showed superior efficacy to standard plasma-derived therapy in adults with AATD


UK MHRA finds gut microbiome research unreliable across labs
R&D | November 14, 2025

UK MHRA finds gut microbiome research unreliable across labs

False positive rates?ranged from 0% to 41%, meaning some labs incorrectly identified bacteria that weren’t present in the sample


FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma
Drug Approval | October 29, 2025

FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma

The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability


Sanofi’s Efdoralprin Alfa shows superiority in phase 2 Alpha-1 antitrypsin deficiency study
Clinical Trials | October 25, 2025

Sanofi’s Efdoralprin Alfa shows superiority in phase 2 Alpha-1 antitrypsin deficiency study

Efdoralprin Alfa was well tolerated, with a safety profile comparable to plasma-derived therapy


Gilead and Kite to transform cancer care with new data at ESMO 2025
Clinical Trials | October 14, 2025

Gilead and Kite to transform cancer care with new data at ESMO 2025

The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy


MoS Health Patel inaugurates National Virus Research & Diagnostic Laboratory Conclave 2025
News | September 16, 2025

MoS Health Patel inaugurates National Virus Research & Diagnostic Laboratory Conclave 2025

Launches National IVD validation portal and protocols; highlights India’s strengthening health research ecosystem