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AstraZeneca gets FDA approval for Tagrisso for type of NSCLC

AstraZeneca gets FDA approval for Tagrisso for type of NSCLC

AstraZeneca has secured extended approval from the US Food and Drug Administration for using Tagrisso (osimertinib) as an adjuvant treatment of non-small cell lung cancer (NSCLC) in patients whose tumors have a certain type of genetic mutation. According to the FDA, nearly 20% of patients with non-small cell lung cancer will have epidermal growth factor […]

FDA approves BMS’ Opdivo, Yervoy combo for malignant pleural mesothelioma

Bristol Myers Squibb (BMS) has secured approval for Opdivo (nivolumab) and Yervoy (ipilimumab) combination from the US Food and Drug Administration (FDA) for the first-line treatment of unresectable malignant pleural mesothelioma (MPM) in adults. The approval is for Opdivo 360 mg every three weeks with 1 mg/kg every six weeks (injections for intravenous use) of […]

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Deciphera gets Qinlock FDA approval for fourth-line advanced GIST

Qinlock FDA approval : Deciphera Pharmaceuticals has been granted approval from the US Food and Drug Administration (FDA) for Qinlock (ripretinib) in advanced gastrointestinal stromal tumor (GIST) in adult patients who had prior treatment with three or more kinase inhibitors, including imatinib. The decision from the FDA marks Qinlock as the first drug approved in […]

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Selpercatinib FDA approval : Lilly’s therapy approved for treatment of lung and thyroid cancers with RET alteration

Selpercatinib FDA approval : The US Food and Drug Administration (FDA) has approved Eli Lilly and Company’s Retevmo (selpercatinib) capsules for the treatment of three types of tumors – non-small cell lung cancer, medullary thyroid cancer and other types of thyroid cancers. The approvals are for the drug to be used in patients whose tumors […]

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Incyte bags Pemazyre FDA approval for cholangiocarcinoma treatment

Pemazyre FDA approval : US biopharma company Incyte has bagged accelerated approval from the US Food and Drug Administration (FDA) for Pemazyre (pemigatinib) for the treatment of cholangiocarcinoma, a rare type of cancer occurring in the bile ducts. The approval is for adult patients having certain types of previously treated, advanced cholangiocarcinoma. According to the […]

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Astellas, Seattle Genetics bag Padcev FDA approval for advanced urothelial cancer

Padcev FDA approval : Astellas Pharma and Seattle Genetics have bagged accelerated approval from the US Food and Drug Administration (FDA) for Padcev (enfortumab vedotin-ejfv) for the treatment of advanced urothelial cancer, the most common form of bladder cancer. Padcev, which has been co-developed by the two pharma companies, is a Nectin-4-directed antibody and microtubule […]

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Global Blood Therapeutics bags Oxbryta FDA approval for sickle cell disease

Oxbryta FDA approval : Global Blood Therapeutics (GBT), a California-based biopharma company, has bagged approval for Oxbryta (voxelotor) tablets from the US Food and Drug Administration (FDA) for sickle cell disease (SCD). The FDA approval of Oxbryta is for the treatment of adults and children, aged 12 years of age and older, who are suffering […]

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Celgene, Acceleron bag Reblozyl FDA approval for anemia in beta thalassemia

Reblozyl FDA approval : Celgene and Acceleron Pharma have bagged approval from the US Food and Drug Administration (FDA) for Reblozyl (luspatercept-aamt) for the treatment of anemia associated with beta thalassemia in adults who need regular red blood cell (RBC) transfusions. Reblozyl is now the first and only erythroid maturation agent to be approved by […]

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Celgene bags Inrebic FDA approval for myelofibrosis

Inrebic FDA approval : Celgene’s subsidiary Impact Biomedicines, has bagged approval for its oral kinase inhibitor Inrebic (fedratinib) capsules from the US Food and Drug Administration (FDA) for the treatment of certain types of myelofibrosis, a rare bone marrow cancer. Fedratinib FDA approval is for the treatment of adult patients with intermediate-2 or high-risk primary […]

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Ibrance FDA approval : Pfizer breast cancer drug approved for metastatic breast cancer in men

New Ibrance FDA approval : The US Food and Drug Administration (FDA) has extended the approval of Pfizer breast cancer drug Ibrance (palbociclib) to cover the treatment of hormone receptor positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients. Latest Ibrance FDA approval Under the new indication approved […]

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