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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]
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]
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).
Durvalumab is FDA approved for the treatment of urothelial carcinoma and unresectable non-small cell lung cancer after chemoradiation. [ 33 ] Cosibelimab (Unloxcyt) by Checkpoint Therapeutics is a PD-L1 inhibitor developed by Dana Farber, and was approved in the United States in December 2024 for cutaneous squamous cell carcinoma .
The FDA accepts and grants Priority Review to Roche's (RHHBY) sBLA for Tecentriq in combination with carboplatin and etoposide for the initial treatment of patients withextensive-stage small cell ...
The FDA approves Roche's (RHHBY) Tecentriq for expanded use. It grants priority review status to AstraZeneca (AZN) & Merck's (MRK) supplemental applications.
1982: Synthetic "human" insulin approved by the U.S. Food and Drug Administration (FDA), partnered with insulin manufacturer Eli Lilly and Company, who shepherded the product through the FDA approval process. The product was licensed to and manufactured by Lilly, and was the first-ever approved genetically engineered human therapeutic.
The FDA approved Neuralink for its first human clinical trial in May 2023. Last month, Neuralink implanted a device in a third person, with the goal of an additional 20 to 30 implants this year, ...