A successful monoclonal antibody could undergo scale-up several times across the span of its commercial life, each stage presenting new complexities during sterile fill-finish. As more sponsors turn ...

This CDMO insights podcast series continues with a discussion on how the complexities of gene therapies require unique technical expertise, and why early planning with the right partner can help keep ...

Sanofi has completed its acquisition of Blueprint, enhancing its portfolio with a commercialised therapy and expertise focused on SM.

Fangzhou has signed a MoU with Novo Nordisk to collaborate on the management of serious chronic diseases, including obesity and diabetes.

In a recent webinar, industry experts explain how real-world data and patient-centric support can shape regulatory success ...

The FDA’s Oncologic Drugs Advisory Committee has voted against the benefit/risk profile of GSK’s Blenrep just days before the drug’s PDUFA date.

Pharmaceutical companies and manufacturers, including MilliporeSigma (Burlington, US), Simtra BioPharma Solutions (Parsippany, US), Carbogen AMCIS (Bubendorf, Switzerland), and BioNTech (Mainz, ...

FDA reviewers have identified high rates of ocular toxicity as GSK looks to place its blood cancer drug back on the market.

The FDA has approved GSK's Shingrix vaccine (recombinant zoster vaccine or RZV) in a prefilled syringe presentation to prevent shingles.

EURneffy is the first needle-free emergency treatment for anaphylaxis available in the UK. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for EURneffy, an ...

Astellas Pharma has entered a memorandum of understanding (MoU) with the Korea Institute of Startup and Entrepreneurship Development (KISED).

Otsuka Pharmaceutical has signed an agreement to acquire all assets related to Cantargia's early-clinical stage CAN10 programme.