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Results For "authorization"

309 News Found

Meridian Bioscience receives U.S. FDA Emergency Use Authorization for Revogene SARS-CoV-2 molecular assay
Biotech | November 12, 2021

Meridian Bioscience receives U.S. FDA Emergency Use Authorization for Revogene SARS-CoV-2 molecular assay

The company expects to begin shipping this product before the end of its fiscal first quarter, ending December 31, 2021


PerkinElmer receives FDA Emergency Use Authorization for respiratory SARS-CoV-2 Panel
Medical Device | October 07, 2021

PerkinElmer receives FDA Emergency Use Authorization for respiratory SARS-CoV-2 Panel

RT-PCR test detects and differentiates SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus


FDA grants Emergency Use Authorization for next-generation Covid-19 assays
Digitisation | August 19, 2021

FDA grants Emergency Use Authorization for next-generation Covid-19 assays

Thermo Fisher’s kits leverage an updated design from the original TaqPath assays, targeting eight different genes across three regions of the virus that causes Covid-19


QIAGEN receives U.S. FDA emergency use authorization to analyze over 30 samples per hour
Digitisation | August 10, 2021

QIAGEN receives U.S. FDA emergency use authorization to analyze over 30 samples per hour

QIAreach SARS-CoV-2 antigen test, developed in collaboration with Ellume, is easy to use and provides accurate and objective results in 2 to 15 minutes


Dr. Reddy's initiates process for emergency use authorization of Sputnik V
News | February 20, 2021

Dr. Reddy's initiates process for emergency use authorization of Sputnik V

Dr. Reddy's will present the safety profile of the phase 2 study, and interim data of the phase 3 study, which is expected to complete by 2pt February 2021.


Marksans Pharma’s UK Arm Relonchem secures MHRA nod for Exemestane 25mg Tablets
News | November 06, 2025

Marksans Pharma’s UK Arm Relonchem secures MHRA nod for Exemestane 25mg Tablets

Exemestane is a key therapeutic used in the treatment of certain types of breast cancer in postmenopausal women


IKS Health announces generative AI platform built on Google cloud
Digitisation | October 18, 2025

IKS Health announces generative AI platform built on Google cloud

IKS Health's innovative solution orchestrates a roll out of critical operations functions into a unified and efficient connected workflow


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


FDA authorizes first eyeglass lenses to slow progression of pediatric Myopia
News | September 30, 2025

FDA authorizes first eyeglass lenses to slow progression of pediatric Myopia

FDA authorization was based on two years of clinical study data demonstrating that Essilor Stellest lenses significantly slowed myopia progression compared to single-vision control lenses