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Sanofi/Regeneron’s Kevzara approved by FDA for polyarticular juvenile idiopathic arthritis

The chronic disease is designated as one of the three major types of juvenile idiopathic arthritis

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EMA announces launch of two advice pilots to improve clinical trials in Europe

The pilots are part of the Accelerating Clinical Trials in the EU initiative to foster high-quality clinical research

- PMLiVE

Roche’s ALK inhibitor Alecensa granted EC approval to treat early-stage lung cancer

Non-small cell lung cancer represents up to 85% of all lung cancer diagnoses

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Sanofi shares positive late-stage results for Sarclisa in newly diagnosed multiple myeloma

More than 180,000 new cases of the haematological malignancy are diagnosed globally every year

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Biogen’s Qalsody granted EC approval to treat rare form of ALS in adults

Mutations in the SOD1 gene are responsible for an estimated 2% of all ALS cases

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Bristol Myers Squibb’s Opdivo approved by EC for adults with urothelial carcinoma

UC accounts for approximately 90% of all bladder cancers, the ninth most common cancer globally

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Sanofi/Regeneron’s Dupixent recommended by CHMP for uncontrolled COPD

No new treatment approaches have been approved for the respiratory disease in more than a decade

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Sanofi’s multiple myeloma treatment Sarclisa accepted for FDA priority review

The second most common haematologic malignancy is responsible for more than 180,000 new global diagnoses every year

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European Commission finalises joint clinical assessment rules for faster access to medicines

Established under the regulation on Health Technology Assessment, the new rules are set to commence in January 2025

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EC approves Celltrion’s omalizumab biosimilar Omlyclo for immunological conditions

The drug can be used to treat patients with conditions including chronic spontaneous urticaria

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Study reveals inflammation caused by infections could contribute to MS progression

The progressive, neurodegenerative disease is estimated to affect more than 130,000 people in the UK

- PMLiVE

Sanofi, Formation Bio and OpenAI announce AI collaboration to accelerate drug development

The companies will combine data, software and tuned models to bring new medicines to patients more efficiently

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