Application is being reviewed under FDA's Real-Time Oncology Review pilot programme Roche today announced the completion of a supplemental Biologics License Application (sBLA) submission to the US Food and Drug Administration (FDA) for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab), for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
All antitrust approvals required to close the transaction received. Roche and Spark Therapeutics, Inc.
Fixed-dose combination administered under the skin in just minutes, compared to hours with intravenous administration, significantly reducing time spent receiving treatment Phase III FeDeriCa study showed non-inferior pharmacokinetics and comparable efficacy and safety with the fixed-dose combination when compared to intravenous formulations Dat
Accu-Chek SugarView is the first app that determines blood glucose ranges by taking photos with the smartphone camera without the need of a blood glucose meter. It is designed to help non-insulin-dependent people with type 2 diabetes or pre-diabetes live healthier lives in-between doctors' visits.
Approval based on the Phase III IMpower130 study showing the Tecentriq plus chemotherapy combination demonstrated a significant overall survival and progression-free survival benefit Roche today announced that the US Food and Drug Administration (FDA) approved Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [paclitaxel protei
Filing submission includes 12-month data from pivotal FIREFISH and SUNFISH trials in a broad population of people living with Types 1, 2 or 3 SMA Roche today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review for risdiplam, an investigational survival motor neuron-2 (SMN-2) splicing modifier for SMA.
Novel combination regimen includes first-in-class antibody-drug conjugate that specifically targets CD79b Targeted off-the-shelf treatment provides much-needed new option for people with relapsed or refractory diffuse large B-cell lymphoma Polivy approval is based on a phase Ib/II study, the first and only study showing improved response rates a
Roche today announced the Phase III IMspire150 study, in people with previously untreated BRAF V600 mutation-positive advanced melanoma, met its primary endpoint of progression-free survival (PFS). The study showed adding Tecentriq (atezolizumab) to Cotellic (cobimetinib) and Zelboraf (vemurafenib) helped to reduce the risk of disease worsening or death, compared to placebo plus Cotellic and Zelboraf.
Greatest improvement in invasive disease-free survival (iDFS) remains in patients at high risk of recurrence, such as those with lymph node-positive disease with a 28% reduction in the risk of recurrence or death, corresponding to an absolute iDFS benefit of 4.5% at six years With longer follow-up, treatment effect is seen regardless of h
In an updated analysis of the CLL14 study, Venclexta/Venclyxto plus Gazyva/Gazyvaro achieved remissions that were sustained over time in people with previously untreated chronic lymphocytic leukaemia At four-year follow-up of the MURANO study, Venclexta/Venclyxto plus MabThera/Rituxan continued to reduce disease progression compared to a standar
Satralizumab demonstrated robust efficacy, sustained for 144 weeks, in significantly reducing the risk of relapse in combination with baseline immunosuppressant therapy Satralizumab targets the interleukin-6 (IL-6) receptor, a potential key driver of neuromyelitis optica spectrum disorder (NMOSD) NMOSD is a rare, debilitating autoimmune disease
First Phase III cancer immunotherapy study to show an improvement in overall survival and progression-free survival in people with unresectable hepatocellular carcinoma compared with sorafenib Results will be presented in the Presidential session at the European Society for Medical Oncology (ESMO) Asia Congress 2019 Roche will today present positive results from the Phase III IMbrave150 study evaluating Tecentriq (atezolizumab) in combination with Avastin (bevacizumab).
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