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Bimzelx® receives EC approval for plaque psoriasis treatment
The European Commission (EC) have approved UCB’s Bimzelx (bimekizumab) for the treatment of moderate to severe plaque psoriasis.
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Regulation & Legislation
![Gloved hand holding a vial labelled 'COVID-19 Vaccine' with Pfizer and BioNTech logos [Credit: malazzama / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-BioNTech-COVID-19-vaccine-300x278.jpg)
![Gloved hand holding a vial labelled 'COVID-19 Vaccine' with Pfizer and BioNTech logos [Credit: malazzama / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-BioNTech-COVID-19-vaccine-e1629795881701.jpg)
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Pfizer-BioNTech becomes the first FDA-approved COVID-19 vaccine
Pfizer and BioNTech's vaccine is the first to be approved by the FDA for the prevention of COVID-19 in people aged 16 years and older.
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ZyCoV-D becomes world’s first plasmid DNA vaccine for COVID-19
Zydus’ ZyCoV-D received emergency use authorisation (EUA) in India, becoming the world’s first plasmid DNA vaccine for COVID-19.
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Xeljanz® receives EU marketing authorisation for juvenile arthritis
Xeljanz® (tofacitinib) received marketing authorisation in Europe for the treatment of juvenile idiopathic arthritis (JIA) and psoriatic arthritis (PsA).
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Evrenzo™ approved for CKD-related anaemia treatment in EU
The European Commission (EC) has approved Astellas’ Evrenzo™ for adult patients with symptomatic anaemia of chronic kidney disease (CKD).
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FDA approves Jardiance® for heart failure with reduced ejection fraction
The FDA have approved Lilly’s Jardiance (empagliflozin) to treat adults living with heart failure with reduced ejection fraction.
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FDA approve GSK’s Jemperli for patients with dMMR solid tumours
GSK receives FDA accelerated approval for Jemperli for adults with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours.
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MHRA approves COVID-19 Vaccine Moderna in 12-17-year olds
The MHRA has approved the use of the Spikevax vaccine (formerly COVID-19 Vaccine Moderna) in children aged 12-17 years old.
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ICMRA set out recommendations for AI regulation in medicine
The ICRMA has set out recommendations to help regulators tackle the challenges posed by artificial intelligence (AI) in medicine.
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Drug price reduction could have no impact on future approvals, study finds
New research shows that drug price reductions under the US's H.R. 3 policy could have no impact on innovation in the pharmaceutical industry.
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FDA approve a new indication for Xywav to treat chronic sleep disorder
The FDA have granted a first of its kind indication for Xywav for the treatment of idiopathic hypersomnia (IH) in adults.
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New NICE draft guidance recommends abemaciclib for breast cancer
NICE has published draft guidance recommending Eli Lilly's twice-daily pill abemaciclib for advanced HER2-negative breast cancer.
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FDA allows additional COVID-19 vaccine dose for immunocompromised
The FDA has authorised an additional dose of COVID-19 Vaccines Pfizer-BioNTech and Moderna in certain immunocompromised patients.
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MHRA approves Epidyolex® (cannabidiol) for TSC seizure treatment
GW Pharmaceuticals received approval for Epidyolex®(cannabidiol) for the treatment of seizures linked to tuberous sclerosis complex (TSC) in the UK.
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EMA endorses global facilitation of track and trace systems
The European Medicines Agency has endorsed ICMRA recommendations to facilitate the use of track and trace systems for medicinal products at a global level.
