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Imjudo/Imfinz

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Roche’s Enspryng given FDA Priority Review as thyroid eye disease treatment

This is the first and only at-home subcutaneous treatment option for this disease

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Regeneron’s New Drug Application for cemdisiran accepted for review by FDA and EMA

Globally, around 150 to 200 out of every million people have myasthenia gravis

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Roche’s Tecentriq gets FDA Priority Review for specific stage 3 colon cancer

Over one million people are diagnosed globally each year and around 30% of stage 3 patients relapse within five years

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Lilly’s Ebglyss approved by FDA as maintenance dose for atopic dermatitis

This new option for patients allows for as few as six maintenance injections per year

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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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AstraZeneca reports positive phase 3 data for tozorakimab in COPD

COPD affects nearly 400 million people globally and is the third leading cause of death worldwide

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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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AstraZeneca’s Imfinzi approved in EU for early gastric and gastro-oesophageal cancers

This is the first and only perioperative immunotherapy approved to treat early gastric cancers

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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The draft guidance specifically discusses genome editing and RNA-based therapies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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AstraZeneca’s Imfinzi regimen receives positive CHMP opinion for early gastric and gastroesophageal cancer

Gastric cancer is the fifth highest cause of cancer deaths worldwide, with almost a million people diagnosed annually

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