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" A Phase III randomized, double-blind, placebo-controlled study of LEE011 or placebo in combination with tamoxifen and goserelin or a non-steroidal aromatase inhibitor (NSAI) and goserelin for the treatment of premenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer" Drug Clinical Trial

An open-label, multicenter, Phase IIIb study to assess the safety and efficacy of ribociclib (LEE011) in combination with letrozole for the treatment of men and pre/postmenopausal women with hormone receptor positive (HR+) HER2-negative (HER2-) advanced breast cancer (aBC) with no prior hormonal therapy for advanced disease Drug Clinical Trial

Multicenter, open-label, study to evaluate safety,tolerability, pharmacokinetics and, pharmacodynamics of LCZ696 followed by a 52-week randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared with enalapril in pediatric patients from1 month to < 18 years of age with heart failure due to systemic left ventricle systolic dysfunction) Drug Clinical Trial

A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants with Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus with or without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST) Drug Clinical Trial

A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) Drug Clinical Trial

Mid-annual PV Inspection Report 2023 Awareness Article

Lisinopril Risk Minimization Activity - New

Contact lenses and its solutions technical Requirements Workshop

Safety Signal of Atorvastatin and the Risk of Erectile dysfunction Safety Alert

Safety Signal of Progesterone and the Risk of Meningioma Safety Alert