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upadacitinib

- PMLiVE

Bristol Myers Squibb’s New Drug Application for mezigdomide accepted by FDA

Mezigdomide improves progression-free survival in patients with relapsed or refractory multiple myeloma

- PMLiVE

Teva submits FDA application for paediatric Tourette syndrome therapy

Ecopipam could become the first new FDA-approved treatment for paediatric Tourette syndrome in over ten years

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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

- PMLiVE

AbbVie to acquire Apogee Therapeutics in $10.9bn deal

The acquisition includes clinical-stage candidates for atopic dermatitis and asthma

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

Allergan Aesthetics launches Skin Quality Index for aesthetic consultations

Spanning four dimensions of skin health, the framework introduces 15 terms and definitions

- PMLiVE

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

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

- PMLiVE

US FDA launches ultra-rare diseases framework

The draft guidance specifically discusses genome editing and RNA-based therapies

- PMLiVE

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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