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Results For "regulatory"

1528 News Found

FDA completes inspection of Indoco’s API manufacturing facility at Patalganga with zero observations
Drug Approval | September 19, 2025

FDA completes inspection of Indoco’s API manufacturing facility at Patalganga with zero observations

The inspection concluded with zero form 483 observations


AstraZeneca's Saphnelo succeeds in Phase III as self-injectable lupus treatment
Clinical Trials | September 18, 2025

AstraZeneca's Saphnelo succeeds in Phase III as self-injectable lupus treatment

The TULIP-SC trial investigated the efficacy and safety of subcutaneous Saphnelo


Pete Pharma and FABRX announce strategic partnership
News | September 17, 2025

Pete Pharma and FABRX announce strategic partnership

Pete Pharma will leverage FABRX’s extensive foundation of scientific validation to deliver a commercially viable, pharmacy-ready solution in the US


ProBioGen to spearhead GMP manufacturing at Berlin’s gene & cell therapy hub
News | September 17, 2025

ProBioGen to spearhead GMP manufacturing at Berlin’s gene & cell therapy hub

ProBioGen will oversee the design, construction, and operation of the 4,600-square-meter GMP manufacturing unit


Enveric clears FDA feedback milestone, prepares IND submission for EB-003
Clinical Trials | September 17, 2025

Enveric clears FDA feedback milestone, prepares IND submission for EB-003

IND application for EB-003 expected in early 2026


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


Advent to sell generic drugmaker Zentiva to GTCR
News | September 16, 2025

Advent to sell generic drugmaker Zentiva to GTCR

Advent acquired Zentiva from Sanofi in 2018 and transformed the company into a highly successful standalone business