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- PMLiVE

EMA recommends granting marketing authorisation approval for Nezglyal

The treatment is for cerebral adrenoleukodystrophy, a rare neurodegenerative disease

- PMLiVE

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

- PMLiVE

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

- PMLiVE

Biogen and Eisai’s Leqembi study shows nearly 83% of early Alzheimer’s patients remained stable or improved

The real-world findings support the long-term benefits of continuous treatment

- PMLiVE

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

- PMLiVE

EMA celebrates diversity and inclusion in science and healthcare

The EU body underlines its commitment to diverse perspectives in medicines regulation

- PMLiVE

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

- PMLiVE

EMA’s PRIME scheme launches three major new features

The scheme supports the development of treatments targeting unmet medical needs in the EU

- PMLiVE

Eisai and Biogen’s new data shows Alzheimer’s patients choose to stay on Leqembi long-term

The findings were presented at the 20th International Conference on Alzheimer’s and Parkinson’s Diseases in Denmark

- PMLiVE

AstraZeneca’s Imfinzi regimen receives positive CHMP opinion for early gastric and gastroesophageal cancer

Gastric cancer is the fifth highest cause of cancer deaths worldwide, with almost a million people diagnosed annually

- PMLiVE

Sanofi’s Rezurock receives positive CHMP opinion for chronic graft-versus-host disease

Up to 50% of allogeneic haematopoietic stem cell transplant patients develop chronic GVHD

- PMLiVE

Eisai and Biogen’s subcutaneous Leqembi given FDA Priority Review for early Alzheimer’s

Administering the drug subcutaneously rather than intravenously showed similar clinical benefits for patients

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