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646 News Found

CuraTeQ Biologics completes Phase 1 Pharmacokinetics study of biosimilar Denosumab
News | April 09, 2025

CuraTeQ Biologics completes Phase 1 Pharmacokinetics study of biosimilar Denosumab

This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets


Lilly launches Mounjaro in India for treatment of obesity and type 2 diabetes
News | March 24, 2025

Lilly launches Mounjaro in India for treatment of obesity and type 2 diabetes

Adults taking Mounjaro with diet and exercise in a controlled clinical trial lost on average 21.8 kg at the highest dose (15mg) and 15.4 kg at the lowest dose (5mg)


USFDA grants Priority Review for new indication of finerenone for patients with common heart failure
Drug Approval | March 20, 2025

USFDA grants Priority Review for new indication of finerenone for patients with common heart failure

Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure


Zydus receives final approval from USFDA for Eluxadoline Tablets, 75 mg and 100 mg
Drug Approval | March 17, 2025

Zydus receives final approval from USFDA for Eluxadoline Tablets, 75 mg and 100 mg

Eluxadoline is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhoea


Nectar Lifesciences receives 7 observations from EDQM for API facility
News | March 12, 2025

Nectar Lifesciences receives 7 observations from EDQM for API facility

The European regulator will conduct a re-inspection of the facility to verify the compliance


Glenmark Nutrition Awards 2025 celebrates innovation and impact in fight against malnutrition
News | March 10, 2025

Glenmark Nutrition Awards 2025 celebrates innovation and impact in fight against malnutrition

403 entries from 22 states covering 168 districts highlight groundbreaking initiatives vital to improving national nutrition metrics.


USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit
Drug Approval | February 27, 2025

USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit

The observations issued are neither repeated observations nor related to data integrity


Briefs: Syngene International and Cipla
Drug Approval | February 23, 2025

Briefs: Syngene International and Cipla

Cipla Limited has received final approval from the USFDA for the New Drug Application submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’


USFDA issues Form-483 for Piramal Pharma's facility at Turbhe
Drug Approval | February 21, 2025

USFDA issues Form-483 for Piramal Pharma's facility at Turbhe

Observations are largely around improvement of procedures and practices