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Results For "approval"

2614 News Found

Merck receives EU nod for first subcutaneous formulation, promising faster cancer treatment
Drug Approval | November 21, 2025

Merck receives EU nod for first subcutaneous formulation, promising faster cancer treatment

This is the first and only subcutaneous immune checkpoint inhibitor available in Europe


Innovent Biologics’ experimental weight-loss drug achieves breakthrough in Phase 3 trial
Clinical Trials | November 21, 2025

Innovent Biologics’ experimental weight-loss drug achieves breakthrough in Phase 3 trial

Innovent plans to soon submit a new drug application (NDA) to China’s National Medical Products Administration


EMA launches streamlined process to fast-track critical medicines, vaccines
News | November 21, 2025

EMA launches streamlined process to fast-track critical medicines, vaccines

The move is expected to be crucial during health crises


Lupin launches long-acting Risperidone in US
News | November 17, 2025

Lupin launches long-acting Risperidone in US

This marks Lupin’s first commercial product leveraging PrecisionSphere, a proprietary long-acting injectable (LAI) technology


Briefs: Zydus, Divi's Laboratories and Relonchem
News | November 17, 2025

Briefs: Zydus, Divi's Laboratories and Relonchem

FDA closes inspection at Zydus' oncology injectable manufacturing facility in SEZ1, Ahmedabad with 2 observations


EMA recommends authorization of Teizeild to delay Type 1 diabetes onset
Drug Approval | November 17, 2025

EMA recommends authorization of Teizeild to delay Type 1 diabetes onset

This is the first drug to receive a recommendation for this preventative indication in the European Union


FDA approves Promega’s OncoMate test to guide personalised treatment for endometrial cancer
Drug Approval | November 14, 2025

FDA approves Promega’s OncoMate test to guide personalised treatment for endometrial cancer

OncoMate MSI Dx Analysis System is a PCR-based assay designed to evaluate MSI status in tumor tissue