Showing 1672 results
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Press release /Sandoz is seeking approval of biosimilar infliximab for use in all indications of its reference medicine across gastroenterology, rheumatology and dermatology Positive opinion is based on a…
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Press release /– A mean increase in CHOP-INTEND of 17.3 was observed at three months post gene therapy in SMA Type 1 U.S. pivotal trial – – All patients in the therapeutic dose cohort in the Phase 1 trial…
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Press release /ROSALIA study met primary endpoints, confirming proposed biosimilar denosumab matches reference product in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in…
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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 is seeking approval for their proposed biosimilars adalimumab and infliximab for use in all indications of their respective reference medicines, Humira®* and Remicade®** Comprehensive data…
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Press release /Integrated Phase I/lll study for proposed biosimilar denosumab to confirm matching efficacy, safety and immunogenicity with reference medicine[1] Osteoporosis accounts for 8.9m bone fractures…
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Press release /Glatopa is the first FDA-approved, substitutable generic version of Copaxone® 20mg, a treatment for relapsing forms of multiple sclerosis Novartis and Sandoz are driving access to a full…
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Press release /Positive CHMP opinion based on comprehensive package of analytical, pre-clinical and clinical dataBreast and gastric cancers are among most common types of cancer, accounting together for nearly half…
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Press release /Sandoz is seeking approval of proposed biosimilar adalimumab for use in all reference medicine indications including those in rheumatology, gastroenterology and dermatology Positive CHMP opinion…
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Press release /Deal includes reSET®, cleared by FDA for treatment of patients with Substance Use Disorder, and reSET-O(TM), potential treatment pending FDA clearance for patients with Opioid Use Disorder treated…