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1528 News Found

Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection
Drug Approval | October 05, 2025

Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

The NDA submission follows the successful completion of a pivotal Phase III global clinical trial


BMS’s anti-MTBR-Tau granted fast track designation by FDA for Alzheimer’s disease
Drug Approval | October 05, 2025

BMS’s anti-MTBR-Tau granted fast track designation by FDA for Alzheimer’s disease

Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of disease


Amgen’s Phase III data supports FDA label expansion of Repatha
News | October 05, 2025

Amgen’s Phase III data supports FDA label expansion of Repatha

Repatha is now the first and only PCSK9 inhibitor to demonstrate significant reduction of cardiovascular events as both primary and secondary prevention


Winrevair cuts risk of PAH progression by 76% in phase 3 Hyperion trial
Clinical Trials | October 01, 2025

Winrevair cuts risk of PAH progression by 76% in phase 3 Hyperion trial

Hyperion results presented at ERS 2025 and simultaneously published in the New England Journal of Medicine


Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections
Drug Approval | October 01, 2025

Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections

This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company


Gleneagles Hospital Mumbai and Medtronic host conclave on hub & spoke model and AI in healthcare
Healthcare | September 30, 2025

Gleneagles Hospital Mumbai and Medtronic host conclave on hub & spoke model and AI in healthcare

The Hub & Spoke model is designed to extend advanced medical care to a wider community


FDA authorizes first eyeglass lenses to slow progression of pediatric Myopia
News | September 30, 2025

FDA authorizes first eyeglass lenses to slow progression of pediatric Myopia

FDA authorization was based on two years of clinical study data demonstrating that Essilor Stellest lenses significantly slowed myopia progression compared to single-vision control lenses


FDA approves Eli Lilly’s Inluriyo for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer
Drug Approval | September 29, 2025

FDA approves Eli Lilly’s Inluriyo for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer

An estimated 50% of patients with ER+, HER2– metastatic breast cancer will develop an ESR1 mutation during or after exposure to an aromatase inhibitor