Clinical Trials Directive
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
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
EMA orphan drug designation given to ReAlta for graft-versus-host disease therapy
This follows preliminary results from the company's ongoing phase 2 trial
Organon/Henlius announce EMA validation for Perjeta biosimilar HLX11
The reference medicine holds approvals for multiple HER2-positive breast cancer indications
Biogen’s higher dose spinal muscular atrophy regimen accepted for review by EMA/FDA
The neuromuscular disease affects approximately one in every 10,000 babies worldwide
Pfizer/BioNTech’s KP.2-adapted COVID-19 vaccine receives CHMP recommendation
The updated vaccine was shown to generate an improved response against currently circulating variants
Envision Analogue – An Introduction
Powered by primary payer market research, Envision is an online platform that provides forward-looking evaluations and comprehensive strategic direction for market access viability after an oncology product has received positive...