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Bristol Myers Squibb’s Augtyro granted expanded FDA approval for solid tumours

The drug was approved by the US regulator last year to treat ROS1-positive NSCLC

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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

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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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FDA approves Geron’s Rytelo to treat lower-risk myelodysplastic syndrome patients

The oligonucleotide telomerase inhibitor is administered as an intravenous infusion every four weeks

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BMS shares positive phase 3 results for Opdivo/Yervoy combination in liver cancer

Hepatocellular carcinoma accounts for 90% of all liver cancer cases and is often diagnosed at an advanced stage

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Bristol Myers Squibb’s Breyanzi receives FDA approval for mantle cell lymphoma

The rare form of non-Hodgkin lymphoma accounts for around 3% of all NHL cases

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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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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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Bristol Myers Squibb unveils ten-year strategy to improve access to medicines in LMICs

The company has collaborated with the ATOM Coalition to make Opdivo available in select countries

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Bristol Myers Squibb’s Breyanzi granted FDA accelerated approval for follicular lymphoma

The disease accounts for up to 30% of all non-Hodgkin lymphoma cases

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