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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

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

EMA reaffirms guidance on paracetamol use during pregnancy

The guidance follows recent US comments about a possible link to autism

- PMLiVE

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

- PMLiVE

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

- PMLiVE

Organon/Henlius announce EMA validation for Perjeta biosimilar HLX11

The reference medicine holds approvals for multiple HER2-positive breast cancer indications

- PMLiVE

Leveraging the ABPI QR Code Update: Enhancing Prescribing Information Through Best Practices

ABPI's recent update permits QR codes in printed pharmaceutical materials for prescribing information. By ensuring visibility, providing clear instructions, linking directly, and keeping content current, companies can enhance accessibility, ensure...

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