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AZ/MSD’s Lynparza assigned Orphan status in US
pharmatimes
October 19, 2018
AstraZeneca and MSD’s PARP inhibitor Lynparza has been granted orphan drug designation in the US for the treatment of pancreatic cancer.
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EU reviews first PARP inhibitor for breast cancer
pharmatimes
July 18, 2018
MSD and AstraZeneca’s Lynparza will be the first PARP inhibitor to be reviewed in Europe for the treatment of breast cancer, after the European Medicines Agency validated the drug’s marketing application in this setting.
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Lynparza Approved in Japan for BRCA-Mutated Metastatic Breast Cancer
americanpharmaceuticalreview
July 11, 2018
AstraZeneca and Merck announced Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved Lynparza (olaparib) tablets for use in patients with unresectable or recurrent BRCA-mutated (BRCAm), human epidermal growth factor receptor 2 (HER2) neg
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EU regulators widen Lynparza’s reach
pharmatimes
July 09, 2018
European regulators have approved a tablet formulation and new dosing regimen for AstraZeneca and MSD’s Lynparza to treat a wider range of patients with ovarian cancer.
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AZ/MSD pursue wider indication for Lynparza on trial success
pharmatimes
July 04, 2018
AstraZeneca and MSD have unveiled trial results showing that Lynparza significantly extended the time patients with ovarian cancer lived without their disease worsening in the first-line maintenance setting, which could significantly expand the drug’s rea
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US approves AZ/MSD’s Lynparza for breast cancer
pharmatimes
January 16, 2018
US regulators have further expanded the scope of AstraZeneca and MSD’s Lynparza to include treatment of patients with BCRA-mutant metastatic breast cancer.
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FDA accepts regulatory submission for Lynparza in metastatic breast cancer
europeanpharmaceuticalreview
October 19, 2017
Lynparza has the potential to offer a new treatment option for patients with metastatic breast cancer…
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AstraZeneca's Lynparza, armed with new FDA nod, aims to regain share from Tesaro's Zejula
fiercepharma
August 21, 2017
Lynparza, shown here in its capsule form, nabbed a new approval in pill form—and in a much bigger group of patients—weeks after setting up an $8.5 billion partnership with Merck & Co.
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LYNPARZA Receives Additional and Broad Approval in the U.S. for Ovarian Cancer
americanpharmaceuticalreview
August 21, 2017
AstraZeneca and Merck announced that the U.S. Food and Drug Administration (FDA) has granted approval for the PARP inhibitor, LYNPARZA (olaparib), as follows:
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Lynparza significantly reduces risk of disease worsening or death
europeanpharmaceuticalreview
June 12, 2017
AstraZeneca presented positive results from its Phase III OlympiAD trial that showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for patients treated with Lynparza (olaparib) tablets...