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Cinqair

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FDA clears Kyowa Kirin’s skin lymphoma therapy Poteligeo

Becomes the first drug approved to treat Sézary syndrome

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FDA’s Gottlieb lambasts industry’s biosimilar-blocking tactics

Speech coincides with Biosimilars Action Plan

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Sage surges after depression drug gets rapid path to approval

Will be able to file a marketing application based on its phase II trial

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AbbVie, Roche get FDA OK for broader use of Venclexta

The drug is tipped to become a $2.5bn product by 2024

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Pfizer drug gets speedy FDA review for rare heart failure complication

Tafamidis chalked up a comprehensive win in its phase III trials programme

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bluebird bags breakthrough status for CALD gene therapy

News comes after impressive data from a phase II/III trial

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Daily Brief: Gottlieb sets out cell and gene pathway, NICE says no to Chiesi ultra-rare treatment and more

News from the frontline of pharma, biotech and healthcare

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FDA looks to regulate digital tools

US regulator adds new components to digital health plan

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Novo Nordisk fends off Lilly’s GLP-1 challenge in Q1

Insulin specialist bounces back with encouraging signs from Ozempic launch

Sanofi reception

Sanofi’s latecomer PD-1 gets date for FDA verdict

While Keytruda extends its lead, Sanofi makes a late bid to enter PD-1 space

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Otsuka finally gets FDA OK for kidney disease drug

Approval at last for rare disease treatment

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Rigel and Ultragenyx claim approvals for rare drugs

Tavalisse and Crysvita are set to treat patients with chronic ITP and XLH, respectively

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