FDA Approves Radioactive Diagnostic Agent for Neuroendocrine Tumors
Detectnet (copper Cu 64 dotatate) is indicated for use with PET for localization of somatostatin receptor positive neuroendocrine tumors.
All articles by Brian Park, PharmD
Dupilumab Gets Breakthrough Therapy Status for Eosinophilic Esophagitis
The designation was based on results from Part A of a double-blind, placebo-controlled, pivotal phase 3 trial.
FDA Rejects Terlipressin NDA for Hepatorenal Syndrome Type 1
In July 2020, the FDA Cardiovascular and Renal Drugs Advisory Committee narrowly voted 8 to 7 in favor of the approval of terlipressin for HRS-1.
FDA Fast Tracks SSAO Inhibitor for Nonalcoholic Steatohepatitis
TERN-201 is a highly-selective semicarbazide-sensitive amino oxidase inhibitor.
XaraColl Implant Approved for Postop Pain Following Hernia Repair
The approval was based on data from 2 placebo-controlled phase 3 studies that evaluated the efficacy and safety of XaraColl for postoperative pain in 610 adults scheduled for open inguinal hernia surgery.
Results Mixed for Etrolizumab in Ulcerative Colitis
Etrolizumab is an investigational humanized monoclonal anti-ß7 antibody designed to selectively inhibit α4β7 and αEβ7 integrins.
FDA: Drug “In-Use Time” May Be Extended in Certain Cases
has provided guidance to healthcare facilities and providers looking to use certain drugs beyond their labeled “in-use times” due to supply issues related to the coronavirus disease 2019 (COVID-19) pandemic.
FDA Wants More Data on Viaskin Peanut Allergy Patch
The FDA noted that it could not approve the BLA due to concerns regarding “the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor study.”
Ortikos Now Available for Mild to Moderate Crohn Disease
Ortikos, an anti-inflammatory corticosteroid, is approved as a once-daily treatment for mild to moderate active Crohn disease and for maintenance of clinical remission.
Zenocutuzumab Gets Orphan Drug Designation for Pancreatic Cancer
Zenocutuzumab is a first-in-class bispecific antibody that binds to HER2 and HER3 receptors, thereby blocking the interaction of HER3 with its ligand neuregulin 1 (NRG1) or NRG1-fusion proteins.
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