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 ...

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 ...

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

The US FDA has accepted the new drug application (NDA) for BeOne Medicines’ B-cell lymphoma 2 (BCL2) inhibitor, sonrotoclax.

With a population of over 670 million people in ASEAN, the total number of patients experiencing rare diseases and conditions ...

The use of real-world evidence (RWE) began gaining traction decades ago, primarily as a response to the limitation around ...