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Semler Research Centre

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FDA grants Fast Track status for peanut allergy immunotherapy

The treatment uses peptides designed to retrain the immune system to tolerate peanuts

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Novartis’ Pluvicto approved by FDA for metastatic hormone-sensitive prostate cancer

More than 186,000 men are diagnosed each year with mHSPC globally

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EMA recommends granting marketing authorisation approval for Nezglyal

The treatment is for cerebral adrenoleukodystrophy, a rare neurodegenerative disease

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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

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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

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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

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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

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Sanofi announces phase 3 study data for infantile-onset Pompe disease

Pompe disease is a rare, progressive neuromuscular disease, with infantile onset being the most aggressive form

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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

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Sanofi’s Cenrifki approved in Europe for secondary progressive MS without relapses

SPMS is a debilitating stage of MS where patients experience increasing levels of disability

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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

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Sanofi appoints Paulo Fontoura as Global Head of R&D

Fontoura previously held senior leadership roles at Xaira Therapeutics and Roche

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