News about "Bayer"

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 |  105

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 |  220

Bayer to Showcase Low-Dose MRI Contrast Innovation at ECR 2026

Bayer brings next-generation contrast agents and smart radiology solutions to ECR 2026, spotlighting progress in low-dose MRI imaging and clinical innovation.

Bayer | 28/01/2026 | By News Bureau |  376

FDA Grants Orphan Drug Status to BlueRock's OpCT-001

The ODD supports the clinical development of OpCT-001, the first iPSC-derived investigational cell therapy to enter human trials for Retinitis Pigmentosa (RP), a common inherited retinal disease marked by progressive loss of photoreceptor cells.

Bayer | 23/01/2026 | By News Bureau |  284