FDA Grants Breakthrough Therapy Designation for Primary Biliary Cholangitis Therapy
February 20th 2019Seladelpar would be indicated for patients with primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) who have an inadequate response to UDCA or as a monotherapy in adults unable to tolerate UDCA.
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Pembrolizumab, Axitinib Combo for Advanced Kidney Cancer Granted Priority Review Designation
February 18th 2019Officials with the FDA have granted Priority Review to Merck’s supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda) for use in combination with axitinib (Inlyta, Pfizer) as first-line treatment for advanced renal cell carcinoma (RCC).
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