Showing 153 results
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Press release /Submission of proposed biosimilar supported by comprehensive package; aims to expand treatment access for people with multiple sclerosis in US and EUMultiple sclerosis (MS) is a chronic inflammatory…
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Press release /Sandoz pursues US approval for biosimilar pegfilgrastim, a long-acting version of supportive oncology medicine filgrastim Pegfilgrastim is used to reduce the incidence of neutropenia, one…
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Press release /Biologics License Application (BLA) is supported by analytical, pre-clinical and clinical data, proposed biosimilar trastuzumab developed by EirGenix, Inc. Trastuzumab is monoclonal…
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Press release /Rituximab is indicated to treat blood cancers and immunological diseases such as rheumatoid arthritis[1] Sandoz believes the comprehensive data package submitted to the FDA for review confirms…
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Press release /Adalimumab is an anti-TNF medicine used to treat a range of immunological diseases[1] The comprehensive data package provided is expected to demonstrate that Sandoz proposed biosimilar adalimumab…
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Press release /Biologics License Application (BLA) submission supported by Phase III RATIONALE 302 trial, which met primary endpoint of improvement in overall survival (OS) in people with advanced or metastatic…
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Press release /FDA grants crizanlizumab Priority Review based on Phase II data showing prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease, shortening FDA review to six months from…
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Press release /Phase III CANOPY-A trial did not meet primary endpoint of disease-free survival in patients with stages II-IIIA and IIIB completely resected non-small cell lung cancer1Findings will be…
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Press release /By 2020, over 1.5 million people in the US are likely to have wet AMD, the leading cause of blindness in industrialized countries Filing is based on Phase III data from the HAWK and HARRIER…
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Press release /Once-daily QMF149 demonstrated superior improvement in lung function versus mometasone furoate, meeting primary endpoint[1] PALLADIUM is part of Phase III PLATINUM clinical development program,…