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Results For "regulatory-authority"

58 News Found

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


Shilpa Pharma Lifesciences Unit-1 inspected by ANVISA
Drug Approval | July 06, 2025

Shilpa Pharma Lifesciences Unit-1 inspected by ANVISA

The audit has been concluded with no major observations


CCI approves merger between Aster DM Healthcare and Quality Care India
News | April 18, 2025

CCI approves merger between Aster DM Healthcare and Quality Care India

The merged entity ‘Aster DM Quality Care’ will be jointly controlled by Aster Promoters and Blackstone


Teva and Sanofi present new outcome from Phase 2b study of duvakitug
News | February 25, 2025

Teva and Sanofi present new outcome from Phase 2b study of duvakitug

Findings to form the basis for a Phase 3 program, anticipated to start in H2 2025