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.
  • textsms

Merck Eyes Keytruda Indication Update with Phase III Gastric Cancer Data

Merck has announced that its blockbuster drug Keytruda met one of its primary endpoints in a Phase III trial for patients with esophageal cancer. The results are an important step toward full approval of the drug for this indication. Merck is now working with the FDA to update the current indication for Keytruda "to those patients whose tumors are PD-L1 positive" following positive results from ..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 6. 19.
  • textsms