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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

- 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

Bayer launches ‘Anything but Normal’ campaign highlighting women’s health issues

Over 1.5 billion women worldwide – almost one in two women – experience women’s health issues

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Sagimet announces positive results for Ascletis’ denifanstat in moderate to severe acne

Over 50 million people across the US live with acne, a condition with no cure that often requires chronic treatment

- 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

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Bayer’s Kerendia granted FDA approval for new heart failure indication

Approximately 55% of the 6.7 million adults in the US with HF have an LVEF of at least 40%

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Bayer’s Vitrakvi receives full FDA approval for NTRK gene fusion-positive tumours

The US regulator first approved the TRK inhibitor in 2018 under its accelerated approval pathway

- PMLiVE

Organon/Henlius announce EMA validation for Perjeta biosimilar HLX11

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

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