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- 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

EMA celebrates diversity and inclusion in science and healthcare

The EU body underlines its commitment to diverse perspectives in medicines regulation

- 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

Astellas’ application to EMA validated for treatment of muscle-invasive bladder cancer

Bladder cancer affects over 224,000 people annually in Europe, with over 30% of cases being muscle-invasive bladder cancer

- PMLiVE

EMA’s PRIME scheme launches three major new features

The scheme supports the development of treatments targeting unmet medical needs in the EU

- 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

Novo Nordisk elects employee representatives to Board of Directors

The elected employee representatives will join the Board of Directors after the annual general meeting on 26 March 2026

- PMLiVE

Novo Nordisk to invest 432m euros to expand manufacturing facility in Ireland

Construction is expected to be completed in phases from the end of 2027 into 2028

- PMLiVE

US FDA launches ultra-rare diseases framework

The draft guidance specifically discusses genome editing and RNA-based therapies

- PMLiVE

Novo Nordisk and Vivtex partner in deal worth up to $2.1bn

The companies aim to develop next-generation oral medicines for obesity and diabetes

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