Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 23

Results For "US-FDA"

451 News Found

FDA approves combo therapy for Cisplatin-ineligible muscle-invasive bladder cancer patients
Drug Approval | November 23, 2025

FDA approves combo therapy for Cisplatin-ineligible muscle-invasive bladder cancer patients

The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy


Piramal Pharma Solutions’ UK facility bags updated MHRA GMP certification
News | November 21, 2025

Piramal Pharma Solutions’ UK facility bags updated MHRA GMP certification

Grangemouth serves as PPS’s dedicated antibody-drug conjugate development and manufacturing hub


Cardiol Therapeutics wins US patent protection for heart-disease drug platform
News | November 19, 2025

Cardiol Therapeutics wins US patent protection for heart-disease drug platform

The patent will lock in broad protection for the company’s lead therapy CardiolRx and its novel subcutaneous candidate CRD-38


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


Aurobindo Pharma gets 9 observations from USFDA for Unit 2 of Eugia Pharma Specialities
News | November 15, 2025

Aurobindo Pharma gets 9 observations from USFDA for Unit 2 of Eugia Pharma Specialities

The observations are procedural in nature and will be responded to within the stipulated time


Marksans Pharma's Goa unit clears FDA inspection
News | November 10, 2025

Marksans Pharma's Goa unit clears FDA inspection

The said inspection concluded with Zero Form 483 observation


Granules India’s facility secures FDA EIR with 'VAI’
Drug Approval | October 30, 2025

Granules India’s facility secures FDA EIR with 'VAI’

The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025