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Johnson & Johnson’s Darzalex Faspro regimen receives FDA approval for multiple myeloma

Multiple myeloma has an average five-year survival rate of 59.8% and is currently incurable

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Eisai and Biogen’s subcutaneous Leqembi given FDA Priority Review for early Alzheimer’s

Administering the drug subcutaneously rather than intravenously showed similar clinical benefits for patients

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

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

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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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Eisai submits new drug application for subcutaneous Leqembi in Japan

LEQEMBI is a treatment for early Alzheimer’s disease

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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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Biogen and Eisai receive MHRA approval for updated dosing of early Alzheimer’s treatment

The MHRA approval for IV dosing comes following positive results from the global phase 3 trial

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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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