Madrigal Pharmaceuticals Initiates Rolling Submission of New Drug Application for Resmetirom to FDA for NASH Treatment

Madrigal Pharmaceuticals, Inc. has announced the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of its drug resmetirom for the treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis. The company expects to complete the full submission of the NDA in July 2023. &nbsp Resmetirom was granted Breakthrough Therap..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 7. 2.
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Gene Editing Race Between Editas and Vertex, CRISPR Heats Up

Gene editing companies Editas Medicine, Vertex Pharmaceuticals and CRISPR Therapeutics are all racing to develop treatments for sickle cell disease (SCD) and transfusion-dependent beta thalassemia. Editas recently unveiled early data from its RUBY and EdiTHAL trials, demonstrating the potential of its gene editor EDIT-301 in treating these diseases. However, Vertex and CRISPR also released posit..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 6. 12.
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Gene Editing Race Between Editas and Vertex, CRISPR Heats Up

The gene editing race between Editas Medicine and Vertex Pharmaceuticals with CRISPR Therapeutics has heated up as both companies released positive data for their sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT) hopeful treatments. Editas Medicine unveiled early data from the RUBY and EdiTHAL trials on Friday, demonstrating the potential of its gene editor EDIT-301 in t..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 6. 11.
  • textsms