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giant cell tumour of the bone

- PMLiVE

Novartis’ ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s disease

Approximately half of those with Sjögren’s disease are thought to be undiagnosed

- PMLiVE

Amgen agrees to lower prescription drug costs in deal with US government

The company has invested $40bn in US R&D and manufacturing in the past seven years

- PMLiVE

FDA approves first gene therapy for Wiskott-Aldrich syndrome

Symptoms of the rare disease include bleeding, eczema and frequent infections

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FDA launches TEMPO digital health pilot

Digital technologies can improve remote patient care for those with chronic diseases

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Richard Pazdur, FDA’s drug evaluation chief, to leave FDA just weeks into new role

Pazdur was previously head of the FDA’s Oncology Center of Excellence

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Merck KGaA given FDA Fast Track designation for generalised myasthenia gravis drug

Cladribine capsules could become the first ever oral treatment for gMG

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Amgen reports positive results from landmark cardiovascular study

The study found significant reductions of major cardiovascular events in high-risk adults following treatment

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Johnson & Jonson secures FDA approval for multiple myeloma treatment

Support for first and only high-risk smouldering multiple myeloma treatment came from positive phase 3 trial results

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GSK’s Blenrep approved by FDA for multiple myeloma

Approval supported by positive results from phase 3 trial

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MHRA and FDA expand collaboration on AI and medtech regulation

National Commission on the Regulation of AI in Healthcare brings together UK and US experts

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Roche’s small cell lung cancer therapy approved by FDA

This is the first and only approved combination therapy for extensive-stage small cell lung cancer

- PMLiVE

Eli Lilly’s Inluriyo approved by FDA for breast cancer

The oral drug can be used to treat advanced or metastatic breast cancer

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