Health news
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,…
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…
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…
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…
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…
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…
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…
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…
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…
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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