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US Congress

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FDA gives Loxo breakthrough tag for second cancer drug

US regulatory body to expect a NDA for LOXO-292 in late 2019

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Daily Brief: setback for Akcea/Ionis, Urovant adds gene therapy, Metrion gains funding

FDA rejects Waylivra, Roivant group continues gene therapy drive, UK biotech gains £637k

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Shire claims US okay for HAE blockbuster-in-waiting

FDA approves Takhzyro as a preventative measure for HAE attacks

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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

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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