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Accelerated approval

- PMLiVE

GSK announces positive results for Blenrep in head-to-head multiple myeloma study

About 176,000 new cases of the blood cancer are diagnosed globally each year

- PMLiVE

Sandoz receives FDA approval for first denosumab biosimilars Wyost and Jubbonti

The biosimilars have been authorised for all indications covered by Amgen's reference medicines

- PMLiVE

Merck KGaA and C4 Therapeutics enter protein degrader partnership worth $756m

The collaboration will utilise C4T’s TORPEDO platform to target and degrade disease-associated proteins

- PMLiVE

GSK’s Jemperli combination recommended by NICE as first-line endometrial cancer treatment

Approximately 580 patients will now be eligible for treatment with the PD-1 inhibitor

- PMLiVE

Sanofi’s Rezurock fast-tracked by NHS for rare chronic graft versus host disease

Around 400 stem cell or bone marrow transplant patients will develop the condition each year in England

- PMLiVE

First UK cancer patients receive Moderna’s experimental mRNA therapy

The Mobilize trial is evaluating mRNA-4359 in cancers including melanoma and lung cancer

- PMLiVE

Johnson & Johnson’s Rybrevant granted FDA approval for lung cancer indications

The drug was previously authorised for use by the US regulator under the accelerated approval pathway

- PMLiVE

FDA awards Orphan Drug Designation to SynaptixBio for rare brain disease therapy

Isolated hypomyelination is a form of TUBB4A leukodystrophy that has been identified relatively recently

- PMLiVE

FDA approves Allecra’s combination antibiotic Exblifep for complicated UTIs

Complicated UTIs account for approximately 19% of all healthcare-associated infections

- PMLiVE

BeiGene’s tislelizumab receives CHMP recommendation for non-small cell lung cancer

Lung cancer is the second most common type of cancer and the leading cause of cancer-related death globally

- PMLiVE

ICR study reveals AstraZeneca’s ceralasertib sensitises tumours to immunotherapy

Results showed that the drug stopped tumour growth in more than half of patients

- PMLiVE

FDA approves Alvotech and Teva’s Simlandi as interchangeable Humira biosimilar

Simlandi is approved to treat multiple indications, including rheumatoid arthritis and Crohn’s disease

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