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FDA approves Sobi’s Gamifant to treat severe inflammatory arthritis complication

The drug is now the first-ever therapy approved in the US to treat MAS in patients with Still's disease

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Sanofi/Regeneron’s Dupixent granted FDA approval for bullous pemphigoid

Around 27,000 adults in the US are living with uncontrolled cases of the chronic skin disease

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Gilead Sciences’ twice-yearly HIV PrEP drug Yeztugo granted FDA approval

More than 100 people in the US were diagnosed with HIV every day in 2023

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FDA approves CSL’s Andembry to prevent hereditary angioedema attacks

The genetic disorder affects approximately one in 10,000 to one in 50,000 people worldwide

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FDA unveils new voucher programme to accelerate drug review process

The programme is designed to reduce the review time for companies supporting US national interests

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FDA approves new presentation of Celltrion’s SteQeyma for paediatric psoriasis

The Stelara biosimilar now offers all dosage forms and strengths of its reference product

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Merck’s perioperative Keytruda regimen approved by FDA for head and neck cancer

More than 72,680 new cases of the disease are expected to be diagnosed in the US this year

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Moderna’s RSV vaccine mRESVIA granted FDA approval to protect younger adults

The vaccine is already approved in the US for use in adults aged 60 years and older

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FDA approves tablet formulation of BeOne’s targeted cancer drug Brukinsa

The new formulation has been authorised for all five indications covered by the original capsule version

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FDA approves Nuvation Bio’s TKI inhibitor Ibtrozi to treat rare form of lung cancer

ROS1-positive non-small cell lung cancer accounts for approximately 2% of new NSCLC cases

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Merck’s RSV monoclonal antibody Enflonsia approved by FDA to protect infants

Enflonsia is now the first RSV preventive for infants that can be given at the same dose regardless of weight

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Merck’s Welireg granted FDA approval to treat rare tumour types PPGL

Up to 2,000 new cases of pheochromocytoma or paraganglioma are diagnosed in the US every year

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