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Results For "regulatory-win"

14 News Found

Roche breaks lab barriers as FDA clears mass spec tests for wider use
News | March 20, 2026

Roche breaks lab barriers as FDA clears mass spec tests for wider use

The newly classified assays join Roche’s Ionify 25-Hydroxy Vitamin D total assay in a growing U.S. portfolio


iRegene doses first US Parkinson’s patient, launches landmark MSA trial in China
Clinical Trials | February 24, 2026

iRegene doses first US Parkinson’s patient, launches landmark MSA trial in China

The move follows encouraging Phase I data and a series of regulatory wins from the U.S. Food and Drug Administration


Neurizon’s ALS drug regimen cleared for launch in Healey platform trial
Clinical Trials | December 12, 2025

Neurizon’s ALS drug regimen cleared for launch in Healey platform trial

The Healey ALS Platform Trial is a multicenter, double-blind, placebo-controlled


Bristol Myers Squibb secures FDA nod for Breyanzi in marginal zone lymphoma
Drug Approval | December 06, 2025

Bristol Myers Squibb secures FDA nod for Breyanzi in marginal zone lymphoma

The one-time CAR T cell infusion now becomes the first and only therapy of its kind cleared for this patient population