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 ...

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

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.

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

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

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

GSK has concluded the acquisition of efimosfermin alfa, an investigational therapeutic for serious liver disease (SLD), from Boston Pharmaceuticals in a $2bn deal. The transaction includes an upfront ...

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

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