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BeiGene’s Brukinsa granted FDA accelerated approval for advanced follicular lymphoma

Approximately 15,000 new cases of follicular lymphoma are diagnosed in the US every year

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Sandoz receives FDA approval for first denosumab biosimilars Wyost and Jubbonti

The biosimilars have been authorised for all indications covered by Amgen's reference medicines

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Pfizer’s RSV vaccine Abrysvo shown to maintain strong efficacy in older adults

RSV infections account for up to 160,000 hospitalisations among older adults each year in the US

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Johnson & Johnson’s Rybrevant granted FDA approval for lung cancer indications

The drug was previously authorised for use by the US regulator under the accelerated approval pathway

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FDA awards Orphan Drug Designation to SynaptixBio for rare brain disease therapy

Isolated hypomyelination is a form of TUBB4A leukodystrophy that has been identified relatively recently

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FDA approves Allecra’s combination antibiotic Exblifep for complicated UTIs

Complicated UTIs account for approximately 19% of all healthcare-associated infections

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FDA approves Alvotech and Teva’s Simlandi as interchangeable Humira biosimilar

Simlandi is approved to treat multiple indications, including rheumatoid arthritis and Crohn’s disease

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Pfizer’s Litfulo recommended by NICE as first treatment for severe alopecia areata

Up to 14,000 patients living with the autoimmune disease could benefit from NICE’s decision

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Johnson & Johnson’s Tecvayli receives FDA approval for reduced dosing in multiple myeloma patients

More than 35,000 cases of the blood cancer are expected to be diagnosed in the US this year

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Pfizer’s Velsipity granted EC approval for ulcerative colitis in patients aged from 16 years

The immune-mediated inflammatory bowel disease affects approximately 2.6 million people in Europe

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AstraZeneca’s Tagrisso combination approved by FDA for advanced lung cancer

An estimated 200,000 people in the US are diagnosed with lung cancer every year

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FDA approves Iovance’s Amtagvi as first cellular therapy for advanced melanoma

Amtagvi is now the first one-time, individualised T cell therapy to be approved in the US for a solid tumour cancer

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