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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

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EMA reaffirms guidance on paracetamol use during pregnancy

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

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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

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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

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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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FDA grants RMAT designation to AskBio’s Parkinson’s gene therapy candidate

The progressive neurodegenerative disease affects more than ten million people worldwide

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Biogen’s higher dose spinal muscular atrophy regimen accepted for review by EMA/FDA

The neuromuscular disease affects approximately one in every 10,000 babies worldwide

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Bayer UK launches digital educational hub to improve menopause support

An estimated 13 million women in the UK are currently perimenopausal or menopausal

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Bayer’s non-hormonal menopause drug shows promise in phase 3 breast cancer trial

Breast cancer patients can experience vasomotor symptoms as a result of adjuvant endocrine therapy

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Pfizer/BioNTech’s KP.2-adapted COVID-19 vaccine receives CHMP recommendation

The updated vaccine was shown to generate an improved response against currently circulating variants

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