cerebral adrenoleukodystrophy
EMA recommends granting marketing authorisation approval for Nezglyal
The treatment is for cerebral adrenoleukodystrophy, a rare neurodegenerative disease
AstraZeneca’s Trixeo recommended by CHMP for approval in EU for asthma
Asthma affects over 360 million people worldwide, including over 40 million people in Europe
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
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
EMA celebrates diversity and inclusion in science and healthcare
The EU body underlines its commitment to diverse perspectives in medicines regulation
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
EMA’s PRIME scheme launches three major new features
The scheme supports the development of treatments targeting unmet medical needs in the EU
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
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
Roche’s Lunsumio receives positive CHMP opinion for follicular lymphoma
The recommendation for the subcutaneous formulation follows encouraging trial data
EMA reaffirms guidance on paracetamol use during pregnancy
The guidance follows recent US comments about a possible link to autism
Johnson & Johnson seeks first EMA approval for icotrokinra for plaque psoriasis
Icotrokinra is a first-in-class, once-daily tablet for moderate-to-severe plaque psoriasis