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The subcutaneous injection of atezolizumab and hyaluronidase was evaluated in IMscin001 (NCT03735121), an open-label, multi-center, international, randomized trial in adults with locally advanced or metastatic non-small cell lung cancer who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. [2]
Atezolizumab, sold under the brand name Tecentriq among others, is a monoclonal antibody medication used to treat urothelial carcinoma, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma and alveolar soft part sarcoma, [9] [11] but discontinued for use in triple-negative breast cancer (TNBC). [12]
A human recombinant hyaluronidase kit, Hyqvia, was approved for use in the European Union in May 2013, [25] and in the United States in September 2014. [ 26 ] [ 27 ] It is a dual vial unit with one vial of immune globulin infusion 10% (human) and one vial of recombinant human hyaluronidase. [ 12 ]
Roche (RHHBY) gets an FDA approval of sBLA for Tecentriq in combination with chemotherapy for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC).
This is the first class of non-opioid pain medication approved to treat moderate to severe acute pain approved by the FDA in more than 20 years. The U.S. Food and Drug Administration (FDA) on ...
Bristol-Myers (BMY) receives EC approval for the label expansion of Sprycel for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in patients aged one to 18 years.
The US Food and Drug Administration (FDA) approved it in March 2017, for the treatment of Merkel-cell carcinoma, [85] an aggressive type of skin cancer. The EMA approved it in September 2017, for the same indication. [87] This is the first FDA-approved treatment for metastatic Merkel-cell carcinoma, a rare, aggressive form of skin cancer. [85]
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