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1375 News Found

TAHO Pharma submits NDA to FDA for world’s first Apixaban oral dissolving film
News | October 06, 2025

TAHO Pharma submits NDA to FDA for world’s first Apixaban oral dissolving film

Pioneering innovation aims to transform anticoagulant therapy and improve patient outcomes


FDA approves Roche’s Tecentriq + lurbinectedin as first-line maintenance therapy for lung cancer
Drug Approval | October 05, 2025

FDA approves Roche’s Tecentriq + lurbinectedin as first-line maintenance therapy for lung cancer

Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study


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


Lupin receives FDA approval Rivaroxaban for oral suspension
Drug Approval | October 01, 2025

Lupin receives FDA approval Rivaroxaban for oral suspension

The product will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India


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


Moderna’s mNEXSPIKE generates strong immune response against LP.8.1 variant in humans
Clinical Trials | September 29, 2025

Moderna’s mNEXSPIKE generates strong immune response against LP.8.1 variant in humans

Both of Moderna's COVID-19 vaccines for the 2025-2026 season have demonstrated strong immune responses against today's top circulating COVID-19 strains


Aptar Pharma opens new R&D center in France
News | September 29, 2025

Aptar Pharma opens new R&D center in France

Expanded capabilities that continue to push the boundaries of innovation—advancing drug delivery solutions for patients, customers, and consumers around the world


Enhertu improved in invasive disease-free survival in early breast cancer in DB-05
Clinical Trials | September 29, 2025

Enhertu improved in invasive disease-free survival in early breast cancer in DB-05

Second positive Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu in HER2-positive early breast cancer reinforces its potential to become a foundational treatment option in curative-intent setting