approvals

The proposed expansion would allow its use in adolescents aged 12 to 17 years with moderate to severe chronic hand eczema (CHE) when topical corticosteroids are inadequate or inappropriate.

Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by recurring symptoms, with the CIC report indicating that China had more than 54 million people living with AD in 2024.

The decision follows positive results from the Phase III VALOR trial (NCT05437263), which showed that Lisraya improved several measures of dermatomyositis disease activity.

Tauklarify’s approval comes as the Alzheimer’s diagnostics field increasingly explores less invasive approaches, particularly blood-based tests for phosphorylated tau (pTau).

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

If approved and launched, the vaccine will complement CanSinoBIO’s recently approved three-component DTaP vaccine, Tripecia® (DT3cP Infant), expanding the company’s pertussis-containing vaccine portfolio across age groups.

Moderna expects to make mFlusiva available in the U.S. ahead of the 2026-2027 respiratory virus season.

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

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