Showing 1387 results
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Ad hoc release /The U.S. Food and Drug Administration (FDA) has not raised any concerns related to the efficacy or safety of inclisiran. The complete response letter is due to unresolved facility inspection-related…
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Press release /Sandoz is seeking approval for all indications included in the reference product's label which includes chronic inflammatory conditions like rheumatoid arthritis and psoriasis. Sandoz believes…
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Press release /Positive opinion paves way for third indication in Europe for Kymriah, a potentially definitive single infusion CAR-T cell therapy treatment optionCHMP opinion based on Phase II global ELARA trial…
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Story /Experts call for significant changes to facilitate the discovery of new treatments.
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Press release /Priority Review based on data from the largest clinical trials conducted to date in each indication[1],[2] Designation will shorten FDA expected review time to within six months[3]; EMA also…
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Press release /Cosentyx (secukinumab) is recommended for approval in Europe for the treatment of ankylosing spondylitis (AS) and psoriatic arthritis (PsA) patients Cosentyx demonstrated rapid onset of…
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Press release /Kymriah demonstrated an overall response rate of 50%, with median duration of response not yet reached at the time of data cut-off, indicating sustainability of response[1] Kymriah is the only…
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Press release /First-in-class therapy showed an 83% (52/63) overall remission rate in this patient population with limited treatment options and historically poor outcomes [1],[2]. Novel approach to cancer…
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Press release /With unique STAMP mechanism of action, Scemblix could provide a new option for patients in Europe with chronic myeloid leukemia (CML) who have suffered intolerance or inadequate response with at…