News about "Bayer"

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

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

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

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

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 |  130

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 |  201

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 |  117

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 |  128

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 |  120

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 |  170