Showing 1406 results
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Press release /FDA Priority Review for capmatinib based on Phase II data in first-line and previously treated patients with MET exon 14 skipping (METex14) mutated advanced non-small cell lung cancer (NSCLC)1 …
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Press release /If approved, relapsed or refractory (r/r) follicular lymphoma would become the third B-cell malignancy indication for Kymriah, joining approvals in children and young adults with r/r ALL, and adults…
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Press release /Filings are supported by Phase III ASCLEPIOS I and II studies, where ofatumumab showed highly significant and clinically meaningful reduction in the number of confirmed relapses, evaluated as…
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Press release /Committee votes unanimously in favor of the Sandoz proposed biosimilar etanercept for all approved indications of the reference product …
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Ad hoc release /Ad hoc announcement pursuant to Art. 53 LR FDA also approved complementary diagnostic imaging agent, Locametz®, after radiolabeling with gallium-68 for the identification of PSMA-positive…
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Press release /CHMP positive opinion advances efforts to provide first-in-class LABA/LAMA/ICS combination for patients whose asthma is uncontrolled with LABA/ICS standard-of-care treatment in the EU. Digital…
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Press release /Data published in the American Journal of Hematology show more than twice as many patients taking crizanlizumab did not experience a disease-related pain crisis (also called vaso-occlusive crisis, or…
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Press release /If approved, Tafinlar + Mekinist will be the first targeted therapy specifically for NSCLC patients with a BRAF V600 mutation CHMP opinion based on positive data from pivotal study of patients…
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Ad hoc release /Kesimpta delivers powerful efficacy with a favorable safety profile and can be self-administered at home, addressing significant unmet needs for people living with relapsing forms of multiple…
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Press release /Votubia is the first adjunctive treatment approved in the EU specifically for partial-onset seizures in children and adults with tuberous sclerosis complex (TSC) Approval addresses unmet…