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Results For "MAA"

55 News Found

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


Dr. Reddy's receives positive CHMP opinion from EMA for denosumab 'AVT03'
News | September 24, 2025

Dr. Reddy's receives positive CHMP opinion from EMA for denosumab 'AVT03'

Prolia is a prescription medicine used to treat osteoporosis in women


Philogen withdraws marketing authorization application for Nidlegy in EU
News | June 26, 2025

Philogen withdraws marketing authorization application for Nidlegy in EU

The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls


RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation
Drug Approval | March 19, 2025

RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation

Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes


Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study
Clinical Trials | February 03, 2025

Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study

Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years


1.48 lakh new TB cases identified in the first 30 days of TB Mukt Bharat -100 Days Intensified Campaign
Policy | January 07, 2025

1.48 lakh new TB cases identified in the first 30 days of TB Mukt Bharat -100 Days Intensified Campaign

Nadda chairs Joint Strategy Meeting with Line Ministries for TB Mukt Bharat Abhiyan- 100-Day Intensified Campaign