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Results For "PLI"

2816 News Found

Linerixibat new drug application accepted for review by the USFDA for cholestatic pruritus in patients with PBC
News | June 07, 2025

Linerixibat new drug application accepted for review by the USFDA for cholestatic pruritus in patients with PBC

If approved, linerixibat could address high unmet medical need of patients living with cholestatic pruritus (relentless itch) and related sleep interference


Merck withdraws Biologics License Application for Patritumab Deruxtecan
Drug Approval | May 30, 2025

Merck withdraws Biologics License Application for Patritumab Deruxtecan

The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance


Sudeep Pharma acquires Nutrition Supplies Services
News | May 30, 2025

Sudeep Pharma acquires Nutrition Supplies Services

This strategic move positions Sudeep Pharma to seamlessly integrate high-end premix capabilities with its mineral portfolio


Caplin Steriles gets USFDA approval for Haloperidol Decanoate Injection
Drug Approval | May 14, 2025

Caplin Steriles gets USFDA approval for Haloperidol Decanoate Injection

Haloperidol Decanoate Injection indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy


Vanta Bioscience receives GLP compliance re-certification
News | May 03, 2025

Vanta Bioscience receives GLP compliance re-certification

This recertification of Company's OECD GLP is testimony to company's unwavering commitment to maintain international quality standards at the facility


Zydus Lifesciences to acquire 85.6 % stake in Amplitude Surgical
News | April 26, 2025

Zydus Lifesciences to acquire 85.6 % stake in Amplitude Surgical

The closing of the Block Acquisition is now expected to be completed by Q3 2025


Caplin Steriles gets USFDA approval for Phytonadione Injectable Emulsion
Drug Approval | April 24, 2025

Caplin Steriles gets USFDA approval for Phytonadione Injectable Emulsion

Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K


Rockwell Automation empowers NKP Pharma achieve regulatory compliance
Digitisation | April 17, 2025

Rockwell Automation empowers NKP Pharma achieve regulatory compliance

By integrating Rockwell Automation’s FactoryTalk Optix, NKP Pharma has achieved compliance with USFDA 21 CFR Part 11


SPARC announces submission of IND Application for SBO-154 to USFDA
News | April 04, 2025

SPARC announces submission of IND Application for SBO-154 to USFDA

The IND application supports the next phase of development of SBO-154


Zydus to acquire majority stake in Amplitude Surgical, France
News | March 12, 2025

Zydus to acquire majority stake in Amplitude Surgical, France

Amplitude Surgical is a European MedTech leader in high-quality, lower-limb orthopaedic technologies