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Results For "marketing-authorization"

183 News Found

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.


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


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.


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


FDA go-ahead to Roche’s one-minute follicular lymphoma therapy
Drug Approval | December 23, 2025

FDA go-ahead to Roche’s one-minute follicular lymphoma therapy

Full approval will depend on verification of clinical benefit in a confirmatory trial


Lupin receives positive CHMP opinion for biosimilar Ranibizumab
Drug Approval | December 18, 2025

Lupin receives positive CHMP opinion for biosimilar Ranibizumab

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A


Glenmark secures exclusive multi-regional rights to Aumolertinib from Hansoh Pharma
News | December 17, 2025

Glenmark secures exclusive multi-regional rights to Aumolertinib from Hansoh Pharma

Hansoh Pharma will receive an upfront payment in the low double-digit millions


EMA backs Eylea 8 mg for retinal vein occlusion
News | December 13, 2025

EMA backs Eylea 8 mg for retinal vein occlusion

The positive CHMP opinion is supported by results from the Phase III QUASAR trial