US Food and Drug Administration (FDA)

Seralutinib is an investigational treatment for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

The new software incorporates AI-powered nodule segmentation, which is designed to generate more precise boundaries around lung nodules during pre-procedural planning.

The approval allows the company’s PGDx elio tissue complete CDx to be used in hospitals and clinical laboratories across the United States to help identify patients who may benefit from targeted treatment.

The approval expands Orzeyful’s commercial reach following its authorization in China in July 2026, marking another milestone in Takeda’s global launch strategy.

DeepHealth Breast Ultrasound automates several stages of breast ultrasound examinations, including lesion detection, characterisation and reporting.

The approval makes Simtriyo the first norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) for ADHD and gives Otsuka what Jefferies analysts described as its “next major CNS launch.”

Lytenava contains bevacizumab, an anti-vascular endothelial growth factor (anti-VEGF) antibody that inhibits the growth of abnormal blood vessels that can damage the retina.

The new reusable sensor features internal optical refinements that improve signal quality and measurement consistency.

The approval marks the first oral PCSK9 inhibitor, offering patients an alternative to injectable therapies traditionally used to reduce LDL cholesterol levels.

Fabhalta, a first-in-class complement factor B inhibitor, initially received accelerated FDA approval in 2024 to reduce proteinuria, or excess protein in the urine, a key indicator of kidney damage.