adaptive pathways
Novartis’ Cosentyx gets positive CHMP opinion for polymyalgia rheumatica
If approved, this would be the first IL-17A inhibitor licensed in Europe for adults with polymyalgia rheumatica
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
NEW WEBINAR: Maximizing Speed-to-Outcome for Life Science Companies
Stop losing momentum to the "logistics lag." The most successful life science teams have moved beyond fragmented spreadsheets and isolated meetings into a unified orchestration engine. Learn the strategies that...
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
ISPOR hosts expert webinar exploring the value of ECAs for regulatory and HTA evidence needs
On Tuesday, October 7th, you are invited to join a Genesis Research Group-led webinar exploring the value of External Control Arm (ECA) studies. Gaining traction as part of evidence generation...