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Media Release /Secondary endpoint data for estimated glomerular filtration rate (eGFR) showed numerical improvement over 6 months vs. placebo1; additional 6-month open-label data to be presented at a future…
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Media Release /Primary results of the Scemblix® ASC4FIRST pivotal Phase III study in first-line Ph+ CML-CP supporting third US FDA Breakthrough Therapy designation, to be detailed in the ASCO Press Program and…
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Media Release /Priority Review based on ASC4FIRST Phase III study with Scemblix® data first to show significantly improved molecular response and a favorable safety and tolerability profile compared to standard…
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Media Release /Addition of Kisqali® (ribociclib) to endocrine therapy (ET) demonstrated a 28% risk reduction in invasive disease-free survival (iDFS) in subgroup of patients with node-negative (N0) disease…
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Media Release /Phase III ASC4FIRST trial met both primary endpoints with clinically meaningful and statistically significant results; Scemblix® (asciminib) demonstrated superior MMR rates at week 48 vs.…
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Media Release /In the ALIGN study, atrasentan, in addition to supportive care with a renin-angiotensin system (RAS) inhibitor, demonstrated a statistically significant 36.1% proteinuria (protein in urine)…
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Media Release /Approval based on NETTER-P trial in which Lutathera demonstrated a consistent safety profile and comparable drug exposure between pediatric (ages 12-17) and adult patients…
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Media Release /Scemblix demonstrated sustained superior major molecular response (MMR) vs. all investigator-selected TKIs (74.1% vs. 52%) and vs. imatinib alone (76.2% vs. 47.1%), meeting both ASC4FIRST 96-week…
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Media Release /Longer-term 96-week results from Scemblix® ASC4FIRST Phase III study in first-line Ph+ CML-CP to be presented following recent FDA approval based on 48-week data Late-breaking Kisqali®* 4-…
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Media Release /Reduction in distant recurrence consistently deepened beyond 3-year Kisqali treatment duration in patients with node-positive (N+) and high-risk node-negative (N0) disease, as well as between…
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