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- PMLiVE

Almirall’s paediatric registration of Ebglyss for atopic dermatitis gets EMA acceptance

Atopic dermatitis affects a significant number of children and adolescents and often peaks in childhood

- 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

EMA celebrates diversity and inclusion in science and healthcare

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

- PMLiVE

Regeneron agrees research collaboration with Parabilis Medicines

Regeneron will pay Parabilis $125m upfront, with up to $2.2bn in potential milestone payments and royalties

- 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

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

- PMLiVE

Sanofi’s Rezurock receives positive CHMP opinion for chronic graft-versus-host disease

Up to 50% of allogeneic haematopoietic stem cell transplant patients develop chronic GVHD

- PMLiVE

Sanofi and Regeneron’s Dupixent receives positive NICE final draft guidance for COPD

Around 1.4 million people in the UK are diagnosed with COPD, with two million thought to be undiagnosed

- PMLiVE

Regeneron’s Libtayo receives EC approval for skin cancer

Phase 3 trial results showed the drug significantly improved disease-free survival

- PMLiVE

Roche’s Lunsumio receives positive CHMP opinion for follicular lymphoma

The recommendation for the subcutaneous formulation follows encouraging trial data

- PMLiVE

EMA reaffirms guidance on paracetamol use during pregnancy

The guidance follows recent US comments about a possible link to autism

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