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Results For "European-Medicines-Agency"

257 News Found

Wockhardt’s WCK 5222 earns accelerated review from European Medicines Agency
News | January 01, 2026

Wockhardt’s WCK 5222 earns accelerated review from European Medicines Agency

The accelerated review covers WCK 5222 for multiple critical infections


GSK’s RSV vaccine ‘Arexvy’ receives positive European Medicines Agency’s  CHMP opinion for adults aged 50-59
Drug Approval | July 30, 2024

GSK’s RSV vaccine ‘Arexvy’ receives positive European Medicines Agency’s CHMP opinion for adults aged 50-59

Decision on EU marketing authorisation for this population expected by September 2024


European Medicines Agency accepts Menarini’s application for Elacestrant
Drug Approval | August 20, 2022

European Medicines Agency accepts Menarini’s application for Elacestrant

Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union


NovoSeven recommended for approval for the treatment of severe postpartum haemorrhage by the European Medicines Agency
Biotech | April 23, 2022

NovoSeven recommended for approval for the treatment of severe postpartum haemorrhage by the European Medicines Agency

Heavy bleeding after giving birth is globally a leading cause of death in new mothers


Shilpa Biologicals' PartnerPower promises real-time transparency in biologics development
Biopharma | June 23, 2026

Shilpa Biologicals' PartnerPower promises real-time transparency in biologics development

New digital platform provides global sponsors with live visibility into R&D, process development and GMP manufacturing operations, enhancing collaboration and decision-making


WuXi Biologics wins fourth EMA certification for Suzhou Biosafety Center
News | June 23, 2026

WuXi Biologics wins fourth EMA certification for Suzhou Biosafety Center

Clearing 19 biologics for Europe market


T-CURX gets Swissmedic nod for first human trial of non-viral CAR-T therapy
Biopharma | June 15, 2026

T-CURX gets Swissmedic nod for first human trial of non-viral CAR-T therapy

Phase 1 study to evaluate Siglec-6-targeted CAR-T therapy in relapsed or refractory AML and CLL patients, marking a major milestone for T-CURX’s scalable non-viral CAR-T platform


Bayer’s asundexian moves into EU regulatory review as stroke prevention race intensifies
News | June 11, 2026

Bayer’s asundexian moves into EU regulatory review as stroke prevention race intensifies

The validation confirms the submission is complete, clearing the way for the EMA’s centralized review process to formally evaluate the therapy


Insect biotech as India's next deeptech opportunity: Ankit Alok Bagaria, Co-founder and CEO, Loopworm
Opinion | June 01, 2026

Insect biotech as India's next deeptech opportunity: Ankit Alok Bagaria, Co-founder and CEO, Loopworm

We have the chance to build an IP estate that goes hand in hand with our generic pharmaceutical strength and build proprietary biological platforms


Wockhardt wins FDA nod for new antibiotic ZAYNICH against drug-resistant infections
Drug Approval | June 01, 2026

Wockhardt wins FDA nod for new antibiotic ZAYNICH against drug-resistant infections

The approval marks a major milestone in the global fight against antimicrobial resistance