Six new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended six medicines for approval at its June 2026 meeting.

The committee recommended granting a marketing authorisation for Aujemflu (influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated), a vaccine to protect people aged 50 years and older against influenza.

The CHMP recommended granting a marketing authorisation for Hopledo (levodopa / carbidopa) for the treatment of adult patients with Parkinson’s disease and moderate-to-severe motor fluctuations (changes in the ability to move) who have not been sufficiently stabilised with oral levodopa/dopa decarboxylase inhibitor-based treatment regimens.

Onswik (insulin efsitora alfa) received a positive opinion from the CHMP for the treatment of type 2 diabetes mellitus in adults.

The committee adopted positive opinions for two biosimilar medicines:

• Denosumab Ascend (denosumab), for the prevention of bone…