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Results For "Marketing-Authorization"

205 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


ZIM Laboratories wins European regulatory milestone with anticoagulant approval in Italy
News | May 23, 2026

ZIM Laboratories wins European regulatory milestone with anticoagulant approval in Italy

The approval was granted by Agenzia Italiana del Farmaco


Venus Remedies secures global approval for Plerixafor in Saudi Arabia
Drug Approval | May 22, 2026

Venus Remedies secures global approval for Plerixafor in Saudi Arabia

SFDA nod marks company’s strategic entry into high-value specialty oncology injectables as it targets expanding stem cell transplant and haemato-oncology market in the GCC region


Bayer’s stroke drug wins fast-track review in US
Drug Approval | May 20, 2026

Bayer’s stroke drug wins fast-track review in US

The development comes as stroke remains one of the world’s biggest health threats


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