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Astellas’ XTANDI (Enzalutamide) Granted European Commission Approval for Use in Additional Recurrent Early Prostate Cancer Treatment Setting
25 Apr 2024 19:27 GMT
… the Phase 3 EMBARK trial in 1,068 men … compared to those treated with leuprolide alone. Participants who were … S. Food and Drug Administration (FDA) for the treatment of patients with … : April 24, 2024.
European Medicines Agency. Meeting highlights from the …
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EC grants label extension approval for Astellas' Xtandi for use in additional recurrent early prostate cancer treatment setting
25 Apr 2024 06:20 GMT
… Food and Drug Administration (FDA) for the treatment of patients … trial were randomized to receive enzalutamide 160 mg daily plus leuprolide … responds to medical or surgical treatment designed to … Pharma Inc. is a pharmaceutical company conducting business in …
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European Commission approves Astellas’ drug for expanded prostate cancer Treatment
24 Apr 2024 14:24 GMT
… the phase 3 Embark trial in 1,068 men … compared to those treated with leuprolide alone. Participants receiving enzalutamide … issued by the Committee for Medicinal Products for Human Use … US Food and Drug Administration (FDA) for the treatment of patients with …
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EC approves Astellas’ Xtandi for high-risk prostate cancer treatment
24 Apr 2024 11:23 GMT
… the trial demonstrated that Xtandi, in combination with leuprolide, significantly … from the Committee for Medicinal Products for Human Use … of the European Medicines Agency (EMA) in … Food and Drug Administration approved Xtandi for the treatment of …
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Astellas' XTANDI™ (Enzalutamide) Granted European Commission Approval for Use in Additional Recurrent Early Prostate Cancer Treatment Setting
24 Apr 2024 02:54 GMT
… Food and Drug Administration (FDA) for the treatment of patients … leuprolide patients.
For more information on the EMBARK trial … responds to medical or surgical treatment designed to … parties.
Information about pharmaceutical products (including products …
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European Commission Approves Astellas' Xtandi For Recurrent Early Prostate Cancer Treatment
24 Apr 2024 01:15 GMT
… deprivation therapy for the treatment of adult men with … alone or in combination with leuprolide reduced the risk of … hormone therapy available for the treatment of high-risk biochemical … S. Food and Drug Administration for the treatment of patients with …
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European Commission Approves Enzalutamide in nmHSPC Subset
25 Apr 2024 18:35 GMT
… trial (NCT02319837).2 The trial assessed enzalutamide plus leuprolide … , the FDA approved enzalutamide plus leuprolide for patients … European Medicine Agency’s Committee for Medicinal Products … recurrent early prostate cancer treatment setting. News release. …
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DR. PETER CHOW: Effectiveness of most common gender-affirming treatments for adolescents not ‘well understood’
12 Apr 2024 16:12 GMT
… treatments are introduced.”
In 2022, France’s National Academy of Medicine advised doctors … to proceed with drugs and … study trials, and those already receiving treatment.
Canada … and estrogen – injectable Leuprolide (Lupron) or oral …
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DSMB recommends continuation of phase 3 trial evaluating central precocious puberty treatment
03 Apr 2024 19:34 GMT
… the injectable emulsion. The trial and evaluation of Leuprolide 42 mg-controlled release … Leuprolide (FP-001) injectable emulsion for the treatment of central precocious puberty. Foresee Pharmaceuticals …
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Foresee Pharmaceuticals to continue Casppian Phase III trial
02 Apr 2024 17:28 GMT
… , a Phase III trial evaluating the efficacy of its leuprolide (FP-001 … from this trial are anticipated in 2025.”
Foresee’s Leuprolide injectable emulsion … and has shown significant treatment effects.
Foresee Pharmaceuticals chairman and CEO Dr …