Showing 1136 results
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Press release /Submissions supported by comprehensive analytical and clinical data package including a Phase I PK/PD similarity study and the integrated Phase I/III ROSALIA clinical trialDenosumab is indicated for…
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Press release /First healthcare industry sustainability-linked bond (SLB) further embeds Environmental Social Governance (ESG) targets into the core of Novartis business operations SLB linked to 2025 Patient Access…
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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 /CHMP positive opinion for EU approval of Tafinlar and Mekinist combination in BRAF V600 mutation-positive melanoma, the most aggressive type of skin cancer FDA grants priority review for…
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Press release /Data from five real-world evidence (RWE) and observational studies being conducted in North America, Latin America and Europe provide extensive cumulative insights for Cosentyx (secukinumab) clinical…
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Press release /Basel, August 6, 2019 – Today the FDA released a statement addressing data integrity issues with the Biologics License Application (BLA) for Zolgensma® (onasemnogene abeparvovec-xioi). First and…
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Press release /Sandoz' biosimilar etanercept candidate shows pharmacokinetic (PK) bioequivalence with no clinically meaningful differences in safety, tolerability and immunogenicity to the originator.[1] …
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Ad hoc release /Cosentyx narrowly missed statistical significance for superiority in ACR 20, the primary endpoint of the EXCEED trial, while showing numerically higher results versus Humira®*[1] Statistically…
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Press release /New Cosentyx® (secukinumab) US label to include 300 mg up-titration option is based on Phase III MEASURE 3 study results in ankylosing spondylitis (AS)1 Label update provides clinicians with…
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Press release /Six African nations will join a partnership pioneered in Ghana using technology to track and better tackle sickle cell disease (SCD) Includes expanded rollout of an app to track babies diagnosed…