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Diurnal

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LEO’s Anzupgo granted FDA approval to treat moderate-to-severe chronic hand eczema

The cream is now the first treatment approved by the regulator specifically for this patient population

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FDA appoints George Tidmarsh as director of CDER

Tidmarsh has most recently been serving as adjunct professor of paediatrics and neonatology at Stanford University

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Johnson & Johnson’s TAR-200 granted FDA priority review to treat bladder cancer

An estimated 84,870 people will be diagnosed with bladder cancer in the US this year

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Bayer’s Kerendia granted FDA approval for new heart failure indication

Approximately 55% of the 6.7 million adults in the US with HF have an LVEF of at least 40%

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FDA publishes over 200 complete response letters in effort to increase transparency

The letters were issued in response to applications submitted to the regulator between 2020 and 2024

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FDA approves Dizal’s oral therapy Zegfrovy to treat advanced lung cancer

Around 226,650 new cases of lung cancer are expected to be diagnosed in the US this year

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Regeneron’s Lynozyfic granted FDA accelerated approval to treat multiple myeloma

More than 36,000 new cases of the blood cancer are expected to be diagnosed in the US this year

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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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