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TransThera Receives Fast Track Designation from FDA for its Core Product TT-00420 to Treat Cholangiocarcinoma prnasia
November 04, 2021
TransThera Sciences (Nanjing) Inc., a clinical-stage biopharmaceutical company focusing on discovering and developing innovative small molecule drug therapies for oncology, inflammatory and cardiovascular diseases...
Servier Announces FDA Approval of TIBSOVO (ivosidenib tablets) in IDH1-Mutated Cholangiocarcinoma firstwordpharma
August 26, 2021
Servier Pharmaceuticals announced today that the U.S. Food and Drug Administration approved TIBSOVO®(ivosidenib tablets) for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation.
Innovent Announces NMPA Acceptance of New Drug Application for the FGFR1/2/3 Inhibitor (Pemigatinib) for the Treatment of Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Ch prnasia
July 09, 2021
Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases announced that the National Medical ...
FDA Approves Truseltiq (infigratinib) for the Treatment of Cholangiocarcinoma drugs
May 31, 2021
and Helsinn Group today announced that (FDA) has approved Truseltiq (infigratinib) under the accelerated approval program for the treatment of patients with previously-treated locally advanced or metastatic CCA harboring an FGFR2 fusion
Innovent Announces First Patient Dosed in China in the Global Phase 3 Clinical Trial of Pemigatinib as the First-line Treatment of Unresectable or Metastatic Cholangiocarcinoma prnasia
May 25, 2021
Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, today announces that the first ...
FDA approves Incyte’s Pemazyre as first targeted treatment for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma pharmaceutical-business-review
April 22, 2020
Incyte announced that the U.S. Food and Drug Administration (FDA) has approved Pemazyre™ (pemigatinib).
FDA Approves First Targeted Treatment for Cholangiocarcinoma americanpharmaceuticalreview
April 21, 2020
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Pemazyre (pemigatinib), the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma.
Innovent Biologics Announces First Patient Dosed in the Pivotal Registrational Trial of Pemigatinib in Patients with Advanced Cholangiocarcinoma in China prnasia
March 04, 2020
The objective of this study is to evaluate the efficacy and safety of pemigatinib in patients with advanced cholangiocarcinoma with FGFR2 fusions or rearrangements who have progressed from at least one prior systemic therapy in China.
Innovent Biologics Announces Positive Updated Result from the Incyte-sponsored Phase II Trial of Pemigatinib in Patients with Previously Treated, Advanced Cholangiocarcinoma En-CPhI.CN
October 21, 2019
Innovent Biologics, Inc., a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune ...
RedHill Biopharma Receives FDA Orphan Drug Designation for YELIVA® for the Treatment of Cholangiocar b3cnewswire
April 05, 2017
Orphan Drug designation allows RedHill to benefit from various development incentives to develop YELIVA® (ABC294640) for cholangiocarcinoma, as well as a seven-year marketing exclusivity period for the indication, if approved for marketing

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