Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 116

Results For "approval"

2479 News Found

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


Lupin receives EIR from FDA for its Aurangabad facility
News | November 13, 2025

Lupin receives EIR from FDA for its Aurangabad facility

The EIR follows a product-specific Pre-Approval Inspection from September 1 to September 5, 2025.


Novartis opens radioligand therapy manufacturing facility in California
News | November 12, 2025

Novartis opens radioligand therapy manufacturing facility in California

New site expands manufacturing footprint to meet future demand; ensures continued on-time delivery rate of >99.9% to patients across western US, Alaska and Hawaii


Shilpa Medicare announces positive Phase 3 results for Oeris
Clinical Trials | November 12, 2025

Shilpa Medicare announces positive Phase 3 results for Oeris

OERIS offers extended antiemetic coverage through a single injection that effectively prevents both acute and delayed CINV for up to five days


FDA grants Orphan Drug Designation for Tinostamustine in malignant glioma
Drug Approval | November 12, 2025

FDA grants Orphan Drug Designation for Tinostamustine in malignant glioma

Tinostamustine is an investigational drug with a potential first-in-class mechanism combining bifunctional alkylating activity and pan histone deacetylase (HDAC) inhibition


Trump clinches historic deal as Lilly, Novo slash U.S. weight-loss drug prices
Policy | November 11, 2025

Trump clinches historic deal as Lilly, Novo slash U.S. weight-loss drug prices

Agreements mark a major victory in the President’s long-term pledge to lower prescription drug costs for Americans