Showing 1672 results
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Press release /Sandoz is seeking approval of high concentration formulation (HCF) adalimumab for use in all indications of reference medicine Upon approval, HCF formulation will offer patients enhanced yet familiar…
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Press release /
AveXis Announces Alignment with FDA on Next Steps Toward a BLA Submission for AVXS-101 in SMA Type 1
– Company to submit information requested by FDA to the IND on an on-going basis – – AveXis plans to request a pre-BLA meeting in Q2 2018 – – Conference call and webcast today at 4:… -
Press release /Collaboration covers proposed trastuzumab biosimilar in Phase III development for human epidermal growth factor receptor 2 positive (HER2+) breast and gastric tumors Per licence agreement,…
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Press release /– Company to expand study of AVXS-101 into additional SMA populations including pre-symptomatic, older pediatric Type 2 and Type 3 SMA patients – – First patient dosed in Phase 1 trial of…
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Story /One patient’s story reveals the hidden obstacles to better health – and opportunities to help clear them.
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In The News /An editorial by Anthony Gitau, Head of Novartis Access in Kenya
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Ad hoc release /Holzkirchen, May 2, 2018 - Sandoz, a Novartis division, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Licensing…
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Press release /Dear SMA community, In January we launched a global Managed Access Program (MAP) for Zolgensma® (onasemnogene abeparvovec). Under this program, we are making up to 100 doses available in 2020 to…
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Ad hoc release /Successful acquisition of Aspen’s Japanese operations and assets reinforces strategic focus on Japan, world’s third largest market for generics and off-patent medicinesAcquired portfolio complements…