News about "Bayer"

US FDA Grants Accelerated Approval to Sevabertinib for Advanced NSCLC

The US Food and Drug Administration (FDA) has granted accelerated approval to sevabertinib for locally advanced or metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) with HER2 (ERBB2) TKD activating mutations.

Bayer | 11/09/2026 | By News Bureau

Bayer Initiates Phase 2 Trial of Investigational GIRK4 Inhibitor for Atrial Fibrillation

Bayer has initiated a global Phase 2 trial of BAY 3670549, an investigational GIRK4 inhibitor being evaluated as a potential treatment for atrial fibrillation and rapid cardioversion.

Bayer | 10/09/2026 | By News Bureau

Bayer's Finerenone Shows Kidney and Cardiovascular Benefits in Hypertensive CKD Subgroup

New FIND-CKD data highlight finerenone’s potential to slow kidney disease progression and reduce cardiovascular-kidney risks in patients with hypertensive nephropathy.

Bayer | 01/09/2026 | By News Bureau |  130

Bayer Files Japan Application to Expand Finerenone Use in Non-Diabetic CKD

Bayer’s Japan filing, backed by Phase III FIND-CKD data showing slower kidney function decline and a 23 percent reduction in cardiovascular-kidney events, seeks to expand finerenone’s potential role in treating adults with non-diabetic CKD and addressing a significant unmet medical need.

Bayer | 31/08/2026 | By News Bureau

Japan Approves Bayer's Sevabertinib for HER2-Mutant NSCLC

Japan approves Bayer’s sevabertinib as the first targeted therapy for HER2-mutant NSCLC, including first-line use, based on phase 1/2 SOHO-01 results.

Bayer | 25/08/2026 | By News Bureau |  120

LYNKUET (Elinzanetant) Gets Expanded Canada Approval for Breast Cancer-Related Hot Flashes

LYNKUET (elinzanetant) receives expanded Canadian authorisation to treat moderate to severe hot flashes and night sweats caused by breast cancer Adjuvant Endocrine Therapy (AET).

Bayer | 18/08/2026 | By News Bureau |  177

China Accepts Bayer's Aflibercept 8 mg Application for RVO Macular Edema Review

China’s National Medical Products Administration (NMPA) accepts aflibercept 8 mg for review in RVO-related macular edema, supported by positive Phase 3 QUASAR results.

Bayer | 14/08/2026 | By News Bureau |  152

Bayer Completes Acquisition of Perfuse Therapeutics

Bayer has completed the acquisition of Perfuse Therapeutics, strengthening its ophthalmology pipeline and expanding its portfolio of innovative eye disease treatments.

Bayer | 19/06/2026 | By News Bureau |  104

Bayer Secures US FDA Approval for Ambelvist, a Low-Dose MRI Contrast Agent

Bayer’s Ambelvist (gadoquatrane) has received US FDA approval for contrast-enhanced MRI in adults and children, offering effective lesion visualization while reducing gadolinium exposure through a low-dose formulation.

Bayer | 16/06/2026 | By News Bureau |  116

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 |  168