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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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Gilead’s Trodelvy approved by EC as first-line treatment for metastatic triple-negative breast cancer

TNBC is the most aggressive type of breast cancer and has historically been difficult to treat

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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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Gilead’s New Drug Application for Yeztugo accepted by US FDA

The investigational once-weekly oral treatment could be the first long-acting pill for HIV prevention

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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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Gilead to acquire Tubulis for up to $5bn

The acquisition builds on Gilead’s oncology pipeline, focused on addressing areas of high unmet need

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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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US FDA launches ultra-rare diseases framework

The draft guidance specifically discusses genome editing and RNA-based therapies

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Gilead to acquire Arcellx in deal worth $7.8bn

The US FDA has accepted a licence application for drug for relapsed/refractory multiple myeloma

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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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