Keytruda Receives Traditional Approval for Some Patients With HER2-Positive Gastric or GEJ Adenocarcinoma

The FDA has granted traditional approval to Keytruda with trastuzumab, fluoropyrimidine- and platinum-containing ...

MARCH 20, 2025

Tevimbra Approved for Treatment of Gastric and Gastroesophageal Junction Cancers in Combination With Chemo

The FDA has approved Tevimbra, in combination with platinum and fluoropyrimidine-based chemotherapy, for the ...

JANUARY 13, 2025

FDA Approves Opdivo Qvantig for Subcutaneous Injection

The FDA approved nivolumab plus hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb) for subcutaneous ...

DECEMBER 30, 2024

Vyloy With Chemotherapy Approved for Gastric or Gastroesophageal Junction Adenocarcinoma

The FDA has approved Vyloy, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line ...

OCTOBER 21, 2024

FDA Amends Keytruda’s Gastric Cancer Indication

The FDA revised the existing indication of pembrolizumab with trastuzumab-, fluoropyrimidine- and ...

NOVEMBER 15, 2023

Opdivo Approved for First-Line Treatment of Advanced or Metastatic GI Cancers

The FDA approved nivolumab (Opdivo, Bristol Myers Squibb), in combination with fluoropyrimidine- and ...

APRIL 27, 2021

FDA Approves Biosimilar Ogivri for Breast, Stomach Cancers

Ogivri is the first biosimilar approved in the United States for the treatment of breast cancer or stomach ...

DECEMBER 1, 2017