Kadcyla
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
AstraZenca’s Etcamah combination therapy given FDA Accelerated Approval for breast cancer
The approval was based on phase 3 trial results showing a 56% risk reduction in disease progression
AstraZeneca and Daiichi Sankyo’s Enhertu plus pertuzumab approved in EU as first-line treatment for breast cancer
This is the first new regimen in more than a decade for first-line treatment for this type of breast cancer
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
Gilead’s Trodelvy approved by EC as first-line treatment for metastatic triple-negative breast cancer
TNBC is the most aggressive type of breast cancer and has historically been difficult to treat
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
Novartis agrees on potential $3bn deal to buy Synnovations’s breast cancer treatment
The oral drug is currently being evaluated for breast cancer and other advanced solid tumours in a phase 1/2 study