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Results For "MAA"

50 News Found

EMA validates MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in two types of cancer
Drug Approval | March 07, 2024

EMA validates MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in two types of cancer

The validations confirm the completion of the applications and commence the scientific review process


EMA accepts LEO Pharma’s MAA for delgocitinib cream in chronic hand eczema
Drug Approval | August 21, 2023

EMA accepts LEO Pharma’s MAA for delgocitinib cream in chronic hand eczema

LEO Pharma is developing delgocitinib cream for the treatment of moderate to severe chronic hand eczema, a hard-to-treat disease where there is a high unmet medical need for treatment


USFDA lifts clinical hold on Phase 3 investigational new drug application for MaaT013
Drug Approval | April 24, 2023

USFDA lifts clinical hold on Phase 3 investigational new drug application for MaaT013

This is the first time the Agency has authorized the Phase 3 clinical evaluation in the U.S of a microbiota-based live biotherapeutic based on a pooling technology


Aurobindo subsidiary submits MAA for oncology biosimilar
Biotech | September 23, 2021

Aurobindo subsidiary submits MAA for oncology biosimilar

CuraTeQ Biologics is on track for filing a second oncology biosimilar


First patient dosed in trial of novel drug targeting limb-threatening artery disease
News | March 16, 2026

First patient dosed in trial of novel drug targeting limb-threatening artery disease

The trial will enroll up to 42 patients in Finland across four cohorts


Veristat expands global trial & regulatory services as Chinese drugmakers push overseas
Clinical Trials | March 14, 2026

Veristat expands global trial & regulatory services as Chinese drugmakers push overseas

The expansion builds on Veristat’s work helping Chinese pharmaceutical firms such as Hansoh Pharma and CStone Pharmaceuticals


Manthan 2026 wraps up, spotlighting India’s life sciences & clinical research future
News | January 20, 2026

Manthan 2026 wraps up, spotlighting India’s life sciences & clinical research future

India in the Changing Landscape of Life-Sciences Research & Development


Wockhardt files marketing authorisation application for WCK 5222 with EMA
News | January 08, 2026

Wockhardt files marketing authorisation application for WCK 5222 with EMA

WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation


Singlera Genomics partners with Pure Medical to bring early cancer detection to Europe
Supply Chain | December 29, 2025

Singlera Genomics partners with Pure Medical to bring early cancer detection to Europe

Singlera and Pure Medical will team up with local universities, hospital networks, and national healthcare systems across Western Europe for research studies


Revvity unveils AI-powered Signals Xynthetica to accelerate molecular and materials design
Digitisation | December 17, 2025

Revvity unveils AI-powered Signals Xynthetica to accelerate molecular and materials design

The Signals Xynthetica solution brings AI-driven in-silico generation, predictive modeling, and experimental validation into a single, governed environment