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Genentech's Gavreto cleared for RET non-small cell lung cancer
pharmatimes
September 08, 2020
US regulators have approved Genentech's Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC).
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Roche’s Genentech gets US FDA approval for Gavreto (pralsetinib)
expresspharma
September 07, 2020
The drug is used to treat metastatic RET fusion-positive non-small cell lung cancer.
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US FDA approves Enspryng from Genentech for neuromyelitis optica spectrum disorder
expresspharma
August 17, 2020
In two randomised controlled Phase III clinical trials, SAkuraStar and SAkuraSky studies, Enspryng demonstrated robust and sustained efficacy and a favourable safety profile in adults with AQP4 antibody-positive NMOSD.
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Genentech secures FDA approval for Evrysdi to treat SMA
pharmaceutical-technology
August 11, 2020
Roche unit Genentech has received approval from the US Food and Drug Administration (FDA) for Evrysdi (risdiplam) to treat spinal muscular atrophy (SMA) in patients aged two months and above.
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Tecentriq misses mark in ovarian cancer trial
pharmatimes
July 15, 2020
Roche and Genentech's Tecentriq (atezolizumab) has failed to hit its primary goal in a late stage trial involving patients with newly diagnosed advanced stage ovarian cancer.
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Genentech gets FDA approval for Tecentriq, Avastin combo for HCC
pharmaceutical-business-review
June 03, 2020
Genentech has secured approval from the US Food and Drug Administration (FDA) for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of unresectable or metastatic hepatocellular carcinoma (HCC).
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FDA approves Genentech’s Tecentriq as first-line monotherapy for certain people with metastatic NSCL
pharmaceutical-business-review
May 21, 2020
Genentech, a member of the Roche Group, announced that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC).
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Genentech secures FDA approval to trial Actemra for Covid-19
pharmaceutical-technology
March 25, 2020
Roche unit Genentech has received US Food and Drug Administration (FDA) approval to conduct a Phase III clinical trial of its rheumatoid arthritis drug Actemra (tocilizumab) ...
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Genentech’s Esbriet gets FDA breakthrough status in uILD
pharmaceutical-technology
March 05, 2020
Roche Group unit Genentech has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for Esbriet (pirfenidone) to treat unclassifiable interstitial lung disease (uILD) in adults.
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Arcus collaborates with Genentech for two randomised clinical studies of AB928
pharmaceutical-business-review
December 25, 2019
Arcus Biosciences announced a clinical collaboration with Genentech, a member of the Roche group, for the evaluation of novel combinations with AB928, Arcus’s dual antagonist of adenosine receptors A2aR and A2bR, for colorectal (CRC) and pancreatic (PDAC)