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Results For "regulatory-approval"

316 News Found

WORK Medical scores regulatory approval for AI-powered blood analyzer
Medical Device | January 01, 2026

WORK Medical scores regulatory approval for AI-powered blood analyzer

It performs white blood cell differential counts and quantifies red blood cell and platelet morphology,


Evofem's SOLOSEC submitted for regulatory approval in the UAE
News | October 06, 2025

Evofem's SOLOSEC submitted for regulatory approval in the UAE

Marks first international filing for Evofem’s single-dose oral treatment


Azenta obtains regulatory approval for clinical long-read whole genome sequencing test
Biotech | November 22, 2024

Azenta obtains regulatory approval for clinical long-read whole genome sequencing test

Performed within GENEWIZ from Azenta Life Sciences' CLIA-certified and CAP-accredited state-of-the-art clinical genomics laboratory


Venus Remedies secures regulatory approvals for three key oncology drugs in Ukraine
News | March 19, 2024

Venus Remedies secures regulatory approvals for three key oncology drugs in Ukraine

Ukrainian marketing approvals for paclitaxel, oxaliplatin and irinotecan mark a significant milestone in the company’s global expansion strategy


Wainua granted first-ever regulatory approval in the US for improving neuropathy impairment
Drug Approval | December 26, 2023

Wainua granted first-ever regulatory approval in the US for improving neuropathy impairment

US FDA approval based on NEURO-TTRansform Phase III results


Pfizer receives regulatory approvals to complete the acquisition of Seagen
News | December 13, 2023

Pfizer receives regulatory approvals to complete the acquisition of Seagen

Announces changes in the commercial organization to incorporate Seagen and improve focus, speed and execution


Navidea Biopharmaceuticals gets regulatory approval of Lymphoaim in India
News | April 19, 2022

Navidea Biopharmaceuticals gets regulatory approval of Lymphoaim in India

Tc99m tilmanocept is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer


Dysval gets regulatory approval in Japan
Drug Approval | March 29, 2022

Dysval gets regulatory approval in Japan

Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients


Guardant Health receives regulatory approval for Guardant360 CDx in Japan
Medical Device | March 14, 2022

Guardant Health receives regulatory approval for Guardant360 CDx in Japan

Guardant360 CDx is a comprehensive genomic profiling test that utilizes blood samples from patients with advanced solid cancers


Novo Nordisk posts strong late-stage results for oral diabetes pill in children and teens
Clinical Trials | April 24, 2026

Novo Nordisk posts strong late-stage results for oral diabetes pill in children and teens

The study evaluated oral semaglutide in young patients with type 2 diabetes and found it delivered a superior reduction in HbA1c