FDA's out­side ex­perts to re­view GSK, As­traZeneca drugs; Biotech gives very ear­ly pos­i­tive in­di­ca­tions for cell ther­a­py

GSK’s much-await­ed ane­mia drug for pa­tients with chron­ic kid­ney dis­ease will be as­sessed by FDA’s out­side ex­perts.

The agency’s car­dio­vas­cu­lar and re­nal drugs ad­vi­so­ry com­mit­tee will re­view the oral drug, dubbed dapro­du­s­tat, on Oct. 26, the British Big Phar­ma said Tues­day. Japan’s health reg­u­la­tor ap­proved the med in June, and the drug is al­so at the Eu­ro­pean Union’s doorsteps. Fil­ings in oth­er re­gions are set to fol­low in the com­ing months, GSK said.

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