Market Access News | pharmaphorum

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Unicycive Therapeutics' hopes of getting FDA approval of its drug for hyperphosphataemia in dialysis patients have been knocked back again.

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Eli Lilly, Regeneron, and five other drugmakers will take part in an FDA pilot designed to make it quicker and easier to set up manufacturing plants.

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Viridian has fired a shot across Amgen's bows with the FDA approval of Tepezza rival Lumvoa in thyroid eye disease, a $2bn market.

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Pressure is building on Amgen to withdraw rare disease therapy Tavneos, after the CHMP recommended its marketing authorisation by revoked in the EU.

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Ibrance has become the first CDK4/6 inhibitor to be approved for a challenging subtype of breast cancer that is often resistant to current treatment.

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Hundreds of women with locally advanced cervical cancer are to be offered MSD's Keytruda on the NHS in England, thanks to new NICE guidance.