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Results For "marketing-authorization"

202 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.


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


Bayer pushes stroke prevention drug forward in China as regulators accept key filing
News | May 02, 2026

Bayer pushes stroke prevention drug forward in China as regulators accept key filing

Stroke is the second-leading cause of death and the third-leading cause of disability worldwide


Moderna wins EU approval for first combined flu & COVID shot for adults 50+
Drug Approval | April 22, 2026

Moderna wins EU approval for first combined flu & COVID shot for adults 50+

The approval, following a positive recommendation from the European Medicines Agency’s CHMP, makes the vaccine valid across all 27 EU member states


Japan okays new long-acting eye drug
News | March 24, 2026

Japan okays new long-acting eye drug

It promises fewer injections for vision loss patients


Sun Pharma scores FDA review for ILUMYA in psoriatic arthritis
News | March 18, 2026

Sun Pharma scores FDA review for ILUMYA in psoriatic arthritis

ILUMYA has already earned FDA approvals for scalp and nail plaque psoriasis in April 2024 and December 2025