The FDA has approved Ekterly (sebetralstat) as the first and only oral on-demand medication for acute attacks of hereditary angioedema (HAE).

J&J is looking to add a hormone-sensitive indication to its prostate cancer therapy, which was originally approved in 2023.

The DoH and Children’s National Hospital in the US have signed a MoU to advance paediatric cell and gene therapy.

Alembic Pharmaceuticals has acquired UTILITY therapeutics, expanding its portfolio with the addition of Pivya to treat uUTIs.

A discussion on formulation development, contract services, and some of the critical considerations when moving from molecule ...

The U.S. Food and Drug Administration’s (FDA’s) evolving guidance on Computer Software Assurance and AI/ML-Based Software ...

As global biopharmas expand into new markets, they introduce more systems to handle increasing data volumes and business operations, building layers of disconnected data, systems, and processes. While ...

Modella AI has signed a multi-year agreement with AstraZeneca for expediting AI-driven oncology clinical development.

The approval comes amid speculation that AstraZeneca CEO Pascal Soriot is considering delisting its UK stock market listing for the US.

By 2030, the cell and gene therapy market is projected to be worth £76.03bn, and logistics is essential in realising the potential.

Biocon Biologics’ Denosumab biosimilars, Vevzuo and Evfraxy, have received marketing authorisation in the European Union (EU).

Brii Biosciences and Joincare Pharmaceutical have signed a licence and technology transfer agreement for BRII-693 for MDR/XDR infections.