Eisai has submitted a new drug application to Japan’s PMDA seeking approval for Leqembi’s SC formulation, SC-AI, for early ...

A new FDA pathway could speed bespoke gene therapies, but key questions over scope and commercial viability remain.

Lupin has FDA approval for Armlupeg 6mg/0.6ml injection in a single-dose prefilled syringe, for subcutaneous use, as a biosimilar to Neulasta.

West Pharmaceutical Services is the winner of the Product Launches Award for Prefillable Syringe Systems in the 2025 ...

The proportion of children receiving a second dose of the MMR vaccine is still below the threshold to stop viral transmission ...

Eydenzelt is subjecting Eylea to further biosimilar erosion, though Regeneron hopes to offset this with two new approvals for Eylea HD.

The UK MHRA has granted approval to Roche Products’ inavolisib to treat adults diagnosed with HR-positive, HER2-negative ...

With an eye on 2026, the healthcare editorial team reflects on key takeaways and trends from recent pharma conferences.

In 2024, over half of patients found to have HIV in Europe received a late diagnosis, which is often associated with poor ...

IASO Biotechnology has received the Hong Kong Department of Health approval for its BLA submitted for the fully human ...

Not long after cutting its sales forecast for 2025, Valneva has decided to decrease its operational footprint in France by ...

This licensing deal falls under SK's wider ploy to harness the growing promise of radiopharmaceuticals within the oncology ...