South San Francisco, CA September 4, 2020 Submitted by Genentech Genentech Announces FDA Approval of Gavreto (pralsetinib) for the Treatment of Adults With Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer Gavreto is a once-daily, oral precision therapy that selectively inhibits…
Tag: Biopharmaceutica
FDA Accepts Genentech’s Supplemental New Drug Application for Xofluza (baloxavir marboxil)
South San Francisco, CA March 6, 2019 Genentech Press Release FDA Accepts Genentech’s Supplemental New Drug Application for Xofluza (baloxavir marboxil) for the Treatment of Influenza in People at High Risk of Complications — XOFLUZA would be the first antiviral…
FDA Grants Priority Review to Genentech’s Personalized Medicine Entrectinib
South San Francisco, CA February 20, 2019 Genentech Press Release Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Applications (NDAs)…
Genentech’s HEMLIBRA® Offers Promise to Hemophilia Patients
South San Francisco, CA August 30, 2018 Press Release Positive Phase III Results for Genentech’s HEMLIBRA® (emicizumab-kxwh) for Hemophilia A Without Factor VIII Inhibitors Published in New England Journal of Medicine — HEMLIBRA prophylaxis significantly reduced bleeds compared to no…
Study Results from Genentech’s Baloxavir Marboxil and Influenza
South San Francisco, CA July 17, 2018 Press Release Phase III CAPSTONE-2 Study Showed That Baloxavir Marboxil Reduced Symptoms in People at High Risk of Complications From the Flu — Baloxavir marboxil – an investigational oral, single-dose antiviral – is…
Genentech Provides Update on First Lampalizumab Phase III Study for Geographic Atrophy, an Advanced Form of Age-Related Macular Degeneration
South San Francisco, CA September 10, 2017 Genentech Press Release Spectri study did not meet its primary endpoint of reducing mean change in geographic atrophy lesion area in patients treated with lampalizumab compared with sham treatment Safety profile was…
FDA Grants Priority Review for Genentech’s Gazyva in Previously Untreated Follicular Lymphoma
South San Francisco, CA August 28, 2017 Genentech Press Release SOUTH SAN FRANCISCO, CA — 2017-08-27 00:00:00 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has…
FDA Grants Priority Review to Genentech’s Emicizumab for Hemophilia A with Inhibitors
South San Francisco, CA August 24, 2017 Genentech Press Release Application based on positive results of Phase III study in adults and adolescents with hemophilia A with inhibitors and interim Phase III results in children — SOUTH SAN FRANCISCO,…
FDA Grants Genentech’s Alecensa Priority Review for Initial Treatment of People with ALK-Positive Lung Cancer
South San Francisco, CA August 2, 2017 Genentech Press Release Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New…
FDA Approves Genentech’s Actemra (Tocilizumab) for Giant Cell Arteritis
South San Francisco, CA May 25, 2017 Genentech Press Release Actemra® is the first FDA-approved treatment for adults with giant cell arteritis (GCA) FDA previously granted Priority Review and Breakthrough Therapy Designation for Actemra in GCA Sixth FDA…