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Results For "authorization"

337 News Found

Moderna to become marketing authorization holder in Japan for Spikevax
News | June 01, 2022

Moderna to become marketing authorization holder in Japan for Spikevax

Companies concluded memorandum of understanding that Takeda will continue to provide distribution support for the Moderna COVID-19 vaccines for a transitional period


Moderna files for authorization of its Covid-19 vaccine in young children six months to six years
Biotech | April 29, 2022

Moderna files for authorization of its Covid-19 vaccine in young children six months to six years

Submission to regulators globally is based on phase 2/3 studies of mRNA-1273 in young children


Sanofi and GSK to seek regulatory authorization for Covid-19 vaccine
News | February 24, 2022

Sanofi and GSK to seek regulatory authorization for Covid-19 vaccine

100% efficacy against severe Covid-19 disease and hospitalizations


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.


Richter’s FYLREVY to transform menopause care in Europe?
News | February 04, 2026

Richter’s FYLREVY to transform menopause care in Europe?

The recommendation covers FYLREVY 14.2 mg and 18.9 mg for non-hysterectomised postmenopausal women experiencing oestrogen deficiency symptoms at least 12 months after their last menses


EU green light to IntraBio’s AQNEURSA for rare neurological disease Niemann-Pick Type C
News | January 28, 2026

EU green light to IntraBio’s AQNEURSA for rare neurological disease Niemann-Pick Type C

The approval is grounded in data from a Phase III randomized, double-blind, placebo-controlled, crossover study in NPC patients