Regulatory Approvals

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

Repatha lowers low-density lipoprotein cholesterol (LDL-C), a key risk factor for cardiovascular disease, alongside other measures to manage cardiovascular risk.

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.”

The approval provides consumers with an additional non-prescription option for managing common types of temporary pain.

The approval follows a positive recommendation issued in April 2026 by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

The US Food and Drug Administration (FDA) approved Jideytro for adults with locally advanced or metastatic ROS1-positive NSCLC who have previously received treatment with a ROS1 kinase inhibitor.

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

The approval expands the use of the therapy to delay the onset of Stage 3 Type 1 diabetes in children as young as one year old.

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.