Genentech
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 22, 2019
Atezolizumab Combo Regimen Approved for ES-SCLC
Tecentriq (Genentech) is the first new treatment option for this type of lung cancer in more than 20 years, ...
MARCH 19, 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 Herceptin Hylecta for Breast Cancer
Herceptin Hylecta is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an ...
FEBRUARY 28, 2019
FDA Approves Ontruzant, Biosimilar to Herceptin
Ontruzant was approved for all eligible indications as the reference product: as an adjuvant therapy for ...
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
Truxima can be used to treat three types of adults with non-Hodgkin lymphoma.
NOVEMBER 29, 2018
FDA Modifies Indications of Pembrolizumab, Atezolizumab
The FDA modified the urethal cancer indications of Keytruda and Tecentriq, limiting their use to patients who are ...
JULY 3, 2018
Venclexta Approved for CLL/SLL After 1 Prior Therapy
The FDA granted regular approval to venetoclax in patients with chronic lymphocytic leukemia (CLL) or small ...
JUNE 18, 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 14, 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 1, 2017
FDA Approves First Hemophilia A With Inhibitors Treatment in 20 Years
Genentech's Hemlibra is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes ...
NOVEMBER 17, 2017
