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evobrutinib

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AstraZeneca and Ionis’ Wainua granted FDA approval for rare disease ATTRv-PN

ATTRv-PN leads to peripheral nerve damage with motor disability within five years of diagnosis

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FDA establishes advisory committee for genetic metabolic disease treatments

The committee will evaluate the potential benefits and risks of new therapies for diagnosis, prevention and treatment

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FDA grants fast track designation to Candel’s immunotherapy in pancreatic cancer

The disease is the fourth leading cause of cancer-related death in the US, accounting for 3.3% of new cancer cases

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FDA approves two cell-based gene therapies for sickle cell disease

Vertex/CRISPR and bluebird bio’s gene therapies have been approved to treat patients aged 12 years and older

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Merck gains rights to Abbisko’s pimicotinib in deal worth over $70m

The candidate is currently in late-stage development for tenosynovial giant cell tumour

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Novartis’ Fabhalta approved by FDA as first oral monotherapy for rare blood disease PNH

The rare blood disease is estimated to affect only ten to 20 people per million worldwide

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Eli Lilly’s Jaypirca granted FDA accelerated approval for non-Hodgkin lymphomas

Approximately 18,740 new cases of CLL have been diagnosed in the US this year

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New study finds dose of subcutaneous cladribine could predict MS relapse risk

The disease affects approximately 130,000 people in the UK and currently has no cure

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FDA to investigate risk of T-cell malignancy from CAR-T cell immunotherapies

The regulator will monitor approved BCMA- or CD19-directed autologous CAR-T cell immunotherapies

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FDA approves SpringWork’s Ogsiveo as first therapy for desmoid tumours

Approximately 1,650 people in the US are diagnosed with the rare non-cancerous tumours each year

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Stem cell therapy trial shows promising results for treating progressive MS

The early-stage trial shows the potential to develop an advanced cell therapy treatment

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Pfizer and Astellas’ Xtandi approved by FDA for earlier prostate cancer indication

Xtandi is the first androgen receptor signalling inhibitor approved for this patient population

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