Shorla Oncology Announces Licensing Agreement and Strategic Partnership for Rights to Market Chemotherapy Drug, PIP-101, in the United States

Shorla Oncology Announces Licensing Agreement and Strategic Partnership for Rights to Market Chemotherapy Drug, PIP-101, in the United States &nbsp The developer is a United Kingdom-based drug development and manufacturing company, providing integrated R&D and manufacturing capabilities to accelerate entry of PIP-101 in the U.S. market. Shorla Oncology to receive the exclusive rights to commerci..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 7. 7.
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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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Astellas Submits New Drug Application for Zolbetuximab in Japan

Japanese pharmaceutical company Astellas Pharma has submitted a New Drug Application (NDA) to Japan's Ministry of Health, Labour and Welfare for zolbetuximab, an investigational Claudin 18.2-targeted monoclonal antibody being evaluated as a first-line treatment for patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tu..

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