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canagliflozin

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FDA gives Rare Paediatric Disease designation to Satellite Bio for urea cycle disorders

The mortality rates of UCDs exceeds 25%, with no curative treatment available for newborns

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J&J’s Icotyde approved by US FDA for plaque psoriasis

Plaque psoriasis affects over 125 million people worldwide

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Novo Nordisk’s Awiqli approved by US FDA as once-weekly basal insulin for patients with type 2 diabetes

The insulin is designed as an alternative to daily basal insulin

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BMS’ Opdivo gets expanded FDA and EU approval for Hodgkin lymphoma

This type of cancer is the most common one diagnosed in teenagers

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J&J’s nipocalimab gets FDA Fast Track designation for lupus

The autoimmune disease affects approximately three to five million people globally

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US FDA launches ultra-rare diseases framework

The draft guidance specifically discusses genome editing and RNA-based therapies

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PureTech’s deupirfenidone gets FDA and EC Orphan Drug Designations for idiopathic pulmonary fibrosis

Rare diseases are defined as conditions affecting fewer than 200,000 people in the US or fewer than five in 10,000 individuals in the European Union

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Diabeloop’s DBLG2 receives FDA and CE clearance for automated insulin delivery without meal input

While a lack of meal announcements can lead to lower glycaemic control, it reduces the mental burden for those with type 1 diabetes

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Novo Nordisk announces positive results for CagriSema in type 2 diabetes

CagriSema improved weight loss and blood glucose control compared to semaglutide alone across all tested doses

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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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AstraZeneca and CSPC Pharmaceuticals enter collaboration on weight management therapies

Almost three billion people globally are thought to be either overweight or obese

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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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