generalised myasthenia gravis
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
Bristol Myers Squibb’s New Drug Application for mezigdomide accepted by FDA
Mezigdomide improves progression-free survival in patients with relapsed or refractory multiple myeloma
Teva submits FDA application for paediatric Tourette syndrome therapy
Ecopipam could become the first new FDA-approved treatment for paediatric Tourette syndrome in over ten years
Roche’s Enspryng given FDA Priority Review as thyroid eye disease treatment
This is the first and only at-home subcutaneous treatment option for this disease
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
Roche’s Tecentriq gets FDA Priority Review for specific stage 3 colon cancer
Over one million people are diagnosed globally each year and around 30% of stage 3 patients relapse within five years
Lilly’s Ebglyss approved by FDA as maintenance dose for atopic dermatitis
This new option for patients allows for as few as six maintenance injections per year
EMA celebrates diversity and inclusion in science and healthcare
The EU body underlines its commitment to diverse perspectives in medicines regulation
Regeneron agrees research collaboration with Parabilis Medicines
Regeneron will pay Parabilis $125m upfront, with up to $2.2bn in potential milestone payments and royalties
FDA gives Rare Paediatric Disease designation to Satellite Bio for urea cycle disorders
The mortality rates of UCDs exceeds 25%, with no curative treatment available for newborns