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Rybelsus

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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

- PMLiVE

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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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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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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Risk calculator to prevent heart attacks and strokes in type 2 diabetes patients

About one-third of adults living with diabetes die from a heart or circulatory disease

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Novo Nordisk announces $2.3bn investment to expand production site in France

The investment will increase the manufacturing capacity for Novo's GLP-1 products

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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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Merck receives FDA approval for Keytruda combination in gastric cancer

An estimated 26,500 people in the US will be diagnosed with gastric cancer in 2023

- PMLiVE

AstraZeneca’s Truqap plus Faslodex receives FDA approval for advanced breast cancer

About 290,000 people in the US will be diagnosed with breast cancer in 2023

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