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Astellas’ Xtandi bags NICE approval in prostate cancer
pharmatimes
June 10, 2021
Astellas’ oral treatment Xtandi has received approval from the National Institute for Health and Care Excellence (NICE) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).
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Astellas’ Xtandi bags additional MHRA approval in prostate cancer
pharmatimes
May 13, 2021
Japanese pharma company Astellas has announced that its prostate cancer therapy Xtandi has gained an approval for an additional indication from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
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EC approves Xtandi™ for third prostate cancer indication
europeanpharmaceuticalreview
May 07, 2021
Xtandi™ (enzalutamide) was approved for metastatic hormone-sensitive prostate cancer after it reduced the risk of radiographic progression or death by 61 percent in a trial.
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Pfizer's 4Q Revenues up 12%
contractpharma
February 10, 2021
COVID-19 vaccine BNT162b2, which was granted an EUA in the U.S. in December 2020, contributed $154 million in sales in the quarter.
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Pfizer, Astellas secure expanded FDA approval for XTANDI
pharmaceutical-business-review
December 20, 2019
Pfizer and Astellas Pharma have secured approval for a new indication for XTANDI (enzalutamide) from the US Food and Drug Administration (FDA) to include its use in ...
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Pfizer, Astellas' Xtandi matches J&J's Erleada with new FDA nod
fiercepharma
December 18, 2019
Pfizer and Astellas' stalwart prostate cancer med Xtandi has watched as Johnson & Johnson's challenger, Erleada, picked up the lead in the metastatic, castration-sensitive form of the disease.
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XTANDI® treatment granted priority review by FDA
europeanpharmaceuticalreview
August 27, 2019
XTANDI® sNDA seeks to add an indication for men with prostate cancer that’s spread but is sensitive to hormone therapy.
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Trial Shows XTANDI Significantly Improved Radiographic PFS in Metastatic Hormone-Sensitive Prostate Cancer
americanpharmaceuticalreview
February 13, 2019
Pfizer and Astellas Pharma announced results from the Phase 3 ARCHES trial in men with metastatic hormone-sensitive prostate cancer (mHSPC).....
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the First and Only Oral Treatment for Men with Non-Metastatic and Metastatic Castration-Resistant Prostate Cancer
firstwordpharma
January 15, 2019
Astellas Pharma Canada, Inc., today announced that Health Canada approved an expanded indication for enzalutamide, an androgen receptor inhibitor for the treatment of patients with prostate cancer, following a Priority Review by Health Canada's Therapeuti
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Astellas, Pfizer Announce Positive Top-Line Results from Xtandi Prostate Trial
americanpharmaceuticalreview
December 21, 2018
Astellas Pharma and Pfizer announced the Phase 3 ARCHES trial evaluating Xtandi (enzalutamide) plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC) met ....