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Skyrizi Approved for Moderately to Severely Active Crohn Disease > Colorectal And Other GI Cancers

Category: Colorectal And Other GI Cancers

Skyrizi Approved for Moderately to Severely Active Crohn Disease
Colorectal And Other GI Cancers Crohn Disease Gastroenterology General News

Skyrizi Approved for Moderately to Severely Active Crohn Disease

Steve Duffy June 21, 2022

The Food and Drug Administration (FDA) has approved Skyrizi® (risankizumab-rzaa) for the treatment of moderately to severely active Crohn disease (CD) in adults. The approval was based on data from two phase 3 induction studies,…

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Oral STAT3 Inhibitor Granted Orphan Drug Status for Hepatocellular Carcinoma
Colorectal And Other GI Cancers Gastroenterology General News Oncology

Oral STAT3 Inhibitor Granted Orphan Drug Status for Hepatocellular Carcinoma

Top-Meds April 21, 2022

The Food and Drug Administration (FDA) has granted Orphan Drug designation to TTI-101, an orally delivered, small molecule, STAT3 (signal transducer and activator of transcription 3) inhibitor, for the treatment of hepatocellular carcinoma (HCC). Increased…

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Futibatinib Gets Priority Review for Locally Advanced or Metastatic Cholangiocarcinoma
Colorectal And Other GI Cancers Gastroenterology General News Oncology

Futibatinib Gets Priority Review for Locally Advanced or Metastatic Cholangiocarcinoma

Steve Duffy March 30, 2022

The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for futibatinib in the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2gene rearrangements, including…

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Maintenance of Clinical Remission Observed With Mirikizumab in UC Trial

Steve Duffy December 16, 2021

Positive results were announced from a phase 3 study evaluating mirikizumab, an investigational anti-IL-23p19 monoclonal antibody, as maintenance therapy in patients with moderately to severely active ulcerative colitis (UC). The multicenter, randomized, double-blind, placebo-controlled maintenance…

FDA Rejects Pedmark NDA Again Citing Manufacturing Deficiencies

Steve Duffy November 30, 2021

The Food and Drug Administration (FDA) has issued a second Complete Response Letter (CRL) to Fennec Pharmaceuticals regarding the New Drug Application (NDA) for Pedmark (sodium thiosulfate) for the prevention of ototoxicity associated with cisplatin…

Rivoceranib Designated Orphan Drug for Hepatocellular Carcinoma
Colorectal And Other GI Cancers General News Oncology

Rivoceranib Designated Orphan Drug for Hepatocellular Carcinoma

Steve Duffy November 11, 2021

The Food and Drug Administration (FDA) has granted Orphan Drug designation to rivoceranib for the treatment of hepatocellular carcinoma (HCC). Rivoceranib is an orally administered, small molecule inhibitor of vascular endothelial growth factor receptor 2…

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Novel Multikinase Inhibitor Gets Fast Track Status for Cholangiocarcinoma
Colorectal And Other GI Cancers Gastroenterology General News Oncology

Novel Multikinase Inhibitor Gets Fast Track Status for Cholangiocarcinoma

Top-Meds November 4, 2021

The Food and Drug Administration (FDA) has granted Fast Track designation to TT-00420 for the treatment of patients with cholangiocarcinoma (CCA) who have no standard treatment options. The FDA previously granted Orphan Drug designation to…

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AbbVie Seeks Approval of Risankizumab for Crohn Disease
Colorectal And Other GI Cancers Crohn Disease Gastroenterology Gastrohepatic Disorders General News

AbbVie Seeks Approval of Risankizumab for Crohn Disease

MPR September 21, 2021

AbbVie has submitted a regulatory application to the Food and Drug Administration for risankizumab-rzaa for the treatment of patients 16 years of age and older with moderate to severe Crohn disease. The application is supported…

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Tislelizumab Under Review for Esophageal Squamous Cell Carcinoma
Colorectal And Other GI Cancers Gastroenterology General News Oncology

Tislelizumab Under Review for Esophageal Squamous Cell Carcinoma

MPR September 13, 2021

The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for tislelizumab for the treatment of patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma after prior…

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Tibsovo Approved for IDH1-Mutated Cholangiocarcinoma
Colorectal And Other GI Cancers Gastroenterology General News Oncology

Tibsovo Approved for IDH1-Mutated Cholangiocarcinoma

MPR August 26, 2021

The Food and Drug Administration (FDA) has approved Tibsovo® (ivosidenib) for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved…

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