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Results For "authorization"

327 News Found

Aurobindo's subsidiary to withdraw application for EU marketing authorization of two biosimilars
News | June 26, 2023

Aurobindo's subsidiary to withdraw application for EU marketing authorization of two biosimilars

This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA


Venus Remedies secures marketing authorization from UK MHRA for Cisplatin
News | April 27, 2023

Venus Remedies secures marketing authorization from UK MHRA for Cisplatin

Company intends to increase sales in the UK to approximately 2 million Euros by focusing on seven molecules which are already registered in the country


EMA recommends refusal of the marketing authorization for Lagevrio
News | February 25, 2023

EMA recommends refusal of the marketing authorization for Lagevrio

Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.


Stelis receives recommendation from EMA granting market authorization for Kauliv
Drug Approval | November 14, 2022

Stelis receives recommendation from EMA granting market authorization for Kauliv

Kauliv provides reusable and disposable pen2 device options to cater to the global market demand.


CHMP recommends conditional marketing authorization for Spesolimab for generalized pustular psoriasis flares
News | October 17, 2022

CHMP recommends conditional marketing authorization for Spesolimab for generalized pustular psoriasis flares

CHMP positive opinion is based on evidence from the EFFISAYIL trial, the largest clinical trial in


Dipharma receives regulatory authorization for the new line at Its cGMP pilot plant
Drug Approval | October 09, 2022

Dipharma receives regulatory authorization for the new line at Its cGMP pilot plant

The company increases its efficiency and is able to face the growing demand for its services.


Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age
Drug Approval | September 27, 2022

Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age

The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses


BridgeBio Pharma, Sentynl Therapeutics receive marketing authorization in the EU for fosdenopterin
Drug Approval | September 22, 2022

BridgeBio Pharma, Sentynl Therapeutics receive marketing authorization in the EU for fosdenopterin

NULIBRY is a first-in-class cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A.


USFDA grants emergency use authorization for Novavax COVID-19 vaccine
Drug Approval | August 22, 2022

USFDA grants emergency use authorization for Novavax COVID-19 vaccine

Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.


U.S. FDA grants emergency use authorization for Novavax COVID-19 vaccine
Drug Approval | July 15, 2022

U.S. FDA grants emergency use authorization for Novavax COVID-19 vaccine

Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.