Genentech
FDA Grants New Breast Cancer Indication for Genentech’s Tecentriq
The FDA granted a new indication for Tecentriq plus chemotherapy for the treatment of adults with unresectable ...
APRIL 1, 2019
FDA Halts MM Trial, Deaths Seen in Venclexta Arm
The FDA halted a clinical trial of Venclexta for MM because of an increased risk for death; does not affect ...
MARCH 26, 2019
Atezolizumab Combo Regimen Approved for ES-SCLC
Atezolizumab (Tecentriq, Genentech) is the first new treatment option for this type of lung cancer in more than 20 ...
MARCH 20, 2019
Trazimera, Biosimilar to Herceptin, Gains Approval
A new biosimilar was approved for Herceptin to treat HER2-overexpressing breast cancer and HER2-overexpressing ...
MARCH 12, 2019
FDA Approves New Formulation of Herceptin
The FDA approved trastuzumab and hyaluronidase-oysk injection for subcutaneous use (Herceptin Hylecta, Genentech) ...
MARCH 1, 2019
FDA Approves Ontruzant, Biosimilar to Herceptin
The biosimilar trastuzumab-dttb (Ontruzant, Samsung Bioepis) was approved for all eligible indications of the ...
JANUARY 22, 2019
FDA Approves Herzuma for Breast Cancer
The FDA approved Herzuma, a HER2/neu receptor antagonist biosimilar to Herceptin for breast cancer treatment.
DECEMBER 17, 2018
FDA Approves Truxima, First Biosimilar to Rituxan
The FDA approved rituximab-abbs (Truxima, Celltrion/Teva), the first biosimilar to rituximab (Rituxan, ...
DECEMBER 1, 2018
FDA Modifies UC Indications of Pembrolizumab, Atezolizumab
The FDA modified the urethal cancer indications of Keytruda and Tecentriq, limiting their use to patients who are ...
JULY 9, 2018
FDA Approves Avastin Plus Chemo for Certain Women With Advanced Ovarian Cancer
The FDA granted a new indication for Avastin in combination with chemotherapy, followed by Avastin as a single ...
JUNE 18, 2018
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 4, 2017
FDA Approves Alecensa for NSCLC
The FDA approved a new indication for Genentech's Alecensa, to treat people with anaplastic lymphoma kinase ...
NOVEMBER 7, 2017
