Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 3

Results For "marketing-authorization"

166 News Found

Zydus Lifesciences reports Q1 FY26 net profit at Rs. 1,466.8 Cr
News | August 13, 2025

Zydus Lifesciences reports Q1 FY26 net profit at Rs. 1,466.8 Cr

The company reported revenue from operations at Rs. 6,573.7 crore, up 6 per cent YoY


EMA’s CHMP recommends authorization of Moderna's Covid-19 vaccine Spikevax for SARS-CoV-2 Variant LP.8.1
News | July 27, 2025

EMA’s CHMP recommends authorization of Moderna's Covid-19 vaccine Spikevax for SARS-CoV-2 Variant LP.8.1

Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European Commission authorization decision


Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer
Drug Approval | July 21, 2025

Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer

European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC)


Briefs: Emcure Pharmaceuticals and Gland Pharma
News | July 12, 2025

Briefs: Emcure Pharmaceuticals and Gland Pharma

Emcure Pharmaceuticals successfully completes USFDA PAI of Oncology facility


Bayer submits EU application for Gadoquatrane MRI contrast agent
News | July 11, 2025

Bayer submits EU application for Gadoquatrane MRI contrast agent

It is intended for contrast enhancement in MRI scans


Lupin and Sino Universal Pharmaceuticals sign license and supply agreement for tiotropium DPI in China
News | June 17, 2025

Lupin and Sino Universal Pharmaceuticals sign license and supply agreement for tiotropium DPI in China

SUP will obtain regulatory approvals for selling Tiotropium DPI in China


Briefs: Dr. Reddy's Laboratories, Relonchem,  Shilpa Pharma Lifesciences and Shanmuga Hospital
News | May 18, 2025

Briefs: Dr. Reddy's Laboratories, Relonchem, Shilpa Pharma Lifesciences and Shanmuga Hospital

Shilpa Pharma Lifesciences, Unit-1, received EIR from USFDA


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)


Briefs: Zydus, Alkem Laboratories, Alkem Medtech and Relonchem
Drug Approval | March 19, 2025

Briefs: Zydus, Alkem Laboratories, Alkem Medtech and Relonchem

Alkem Medtech to acquire 100% stake of Bombay Ortho