News

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.
The FDA has approved GSK's Shingrix vaccine (recombinant zoster vaccine or RZV) in a prefilled syringe presentation to prevent shingles.
In a recent webinar, industry experts explain how real-world data and patient-centric support can shape regulatory success ...
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.
Astellas Pharma has entered a memorandum of understanding (MoU) with the Korea Institute of Startup and Entrepreneurship Development (KISED).
Navamedic has completed its previously announced acquisition of dne pharma's business for up to Nkr225m ($22m).
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 ...
Otsuka Pharmaceutical has signed an agreement to acquire all assets related to Cantargia's early-clinical stage CAN10 programme.
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 ...
The label expansion sought by GSK is a bid to compete with Pfizer and Moderna in the younger age groups of the RSV vaccine market. Pfizer’s Abrysvo and Moderna’s mRESVIA are both approved to prevent ...
Both AstraZeneca and MSD have tied lucrative licensing deals for two of LaNova’s oncology assets in recent years.