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.

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 ...

Clinical trials are at a critical moment. Mounting costs, workforce shortages, and poor enrollment rates are having a significant impact on clinical trials. Industry leaders say it’s time for reform, ...

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

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

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

As one FDA initiative works to sustain the momentum of rare disease research, other events threaten to slow progress.

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

Sarepta Therapeutics is set to cut 500 jobs as part of its restructuring and pipeline prioritisation plan, which is expected to result in annual cash cost savings of $120m in 2026. With its pipeline ...

Thermo Fisher Scientific has signed an agreement for the acquisition of Sanofi’s steriles manufacturing site in Ridgefield, New Jersey, US.

This collaboration is the third partnership between JCR and Alexion, following earlier research collaborations involving J-Brain Cargo technology. The first collaboration was announced in March 2023 ...

Due to concerns surrounding its effectiveness, the US Food and Drug Administration (FDA) ended the Rare Pediatric Disease Designation (RPDD) programme in late 2024.