News about "Bayer"

US FDA Approves Bayer's AMBELVIST for Contrast-Enhanced MRI

Bayer’s AMBELVIST (gadoquatrane) has received US FDA approval for contrast-enhanced MRI to detect and visualise lesions with abnormal vascularity in the Central Nervous System (CNS) and other body regions. The approval expands advanced imaging options with a next-generation gadolinium-based contrast agent for improved diagnostic evaluation.

Bayer | 15/06/2026 | By News Bureau

EMA Confirms Asundexian MAA for Assessment in Secondary Prevention of Ischemic Stroke

The EMA has accepted the Marketing Authorisation Application (MAA) for asundexian, the first Factor XIa (FXIa) inhibitor under review in Europe for secondary prevention of ischemic stroke. The submission is supported by positive phase 3 OCEANIC-STROKE data.

Bayer | 11/06/2026 | By News Bureau |  111

Bayer Receives FDA Priority Review for Kerendia in Type 1 Diabetes-Related Kidney Disease

Bayer receives US Food and Drug Administration (FDA) Priority Review (PR) for supplemental approval of Kerendia to treat adults with Type 1 Diabetes (T1D) and Chronic Kidney Disease (CKD), potentially becoming the first Mineralocorticoid Receptor Antagonist (MRA) approved for this patient population.

Bayer | 22/05/2026 | By News Bureau

US FDA Grants Priority Review to HYRNUO for HER2-Mutated NSCLC

The US FDA has granted Priority Review (PR) to HYRNUO (sevabertinib) as a first-line treatment for HER2-mutated Non-Small Cell Lung Cancer (NSCLC), based on phase 1/2 SOHO-01 trial data.

Bayer | 21/05/2026 | By News Bureau

Bayer Wins US FDA Priority Review for Asundexian Stroke Prevention Therapy

Bayer receives US Food and Drug Administration Priority Review (PR) for asundexian to reduce recurrent stroke risk after non-cardioembolic ischemic stroke or transient ischemic attack, supported by positive phase 3 OCEANIC-STROKE trial results.

Bayer | 20/05/2026 | By News Bureau

Bayer Reports Positive Phase 3 Results for Investigational Cardiac Amyloidosis Imaging Agent

REVEAL study demonstrates strong diagnostic sensitivity and specificity of I 124 evuzamitide PET/CT radiotracer for detecting cardiac amyloidosis, supporting plans for regulatory discussions with the FDA.

Bayer | 08/05/2026 | By News Bureau |  124

China's CDE Grants Priority Review to Bayer's FXIa Inhibitor

China’s Center for Drug Evaluation (CDE) grants Priority Review (PR) to Bayer’s FXIa inhibitor, highlighting its potential clinical value in reducing stroke risk.

Bayer | 08/05/2026 | By News Bureau

Bayer to Acquire Perfuse Therapeutics to Boost Ophthalmology Pipeline

Bayer to acquire Perfuse Therapeutics, strengthening its ophthalmology pipeline with a potential disease-modifying therapy for glaucoma and diabetic retinopathy.

Bayer | 07/05/2026 | By News Bureau

Bayer Updates Access Model for Eylea 2mg in India

Bayer revises its access model for Eylea 2mg in India to expand patient eligibility and reduce upfront costs, enabling earlier treatment for retinal diseases.

Bayer | 08/04/2026 | By News Bureau

Alvotech Reaches Global Settlement on Eylea Biosimilar

The settlement enables Alvotech and its partners to launch the biosimilar from January 1, 2026 in the UK and Canada, from May 1, 2026 in the EEA and other markets outside the US, and in Japan from May 2026 for select indications, expanding to all approved indications from November 1, 2026.

Bayer | 30/01/2026 | By News Bureau |  239