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Results For "marketing-authorization"

169 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


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


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


Briefs: Relonchem, Patel Chem Specialities and J & H Pharma Consultants
News | September 24, 2025

Briefs: Relonchem, Patel Chem Specialities and J & H Pharma Consultants

Relonchem receives marketing authorization for Moxonidine tablets