Cholangiocarcinoma Archives

FDA Action Alert: Evofem, Sanofi, Regeneron and Incyte

Approvals, Atopic Dermatitis, Cholangiocarcinoma, FDA/Regulatory, New Drug Applications, PDUFA, Pregnancy Prevention, Supplemental Biologics License Application (sBLA)

A look at the U.S. Food and Drug Administration’s drug approval review calendar.

May 26, 2020/by BioSpace

FDA Approves Incyte’s Pemazyre as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma

Approvals, Breakthrough Therapy Designation, Cholangiocarcinoma, FDA, FDA/Regulatory, New Drug Applications, Orphan Drug Designation

The U.S. Food and Drug Administration approved Incyte’s Pemazyre (pemigatinib), a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement as detected by an FDA-approved test.

April 17, 2020/by Business Wire