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BioWorld - Friday, June 19, 2026
Home » Topics » Regulatory

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FDA approves Zeposia as oral treatment for relapsing forms of multiple sclerosis

March 27, 2020

Regulatory front for March 26, 2020

March 26, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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In the clinic for March 26, 2020

March 26, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Castle Biosciences.
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BMS wins FDA approval for new once-daily MS drug, ozanimod

March 26, 2020
By Michael Fitzhugh
Barely a day after its PDUFA date, despite the unfolding COVID-19 pandemic, the FDA has approved Bristol Myers Squibb Co.'s immunomodulator, ozanimod, an oral treatment for adults with relapsing-remitting multiple sclerosis (MS) and active secondary progressive disease branded as Zeposia. The win, a much-anticipated milestone precipitated by the company’s multibillion-dollar acquisition of ozanimod developer Celgene Corp. in November 2019, gives patients a new treatment option amid a growing field of therapies for MS.
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Regulatory front for March 26, 2020

March 26, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Japan first in world to approve Viltepso for Duchenne muscular dystrophy

March 26, 2020

Velexbru approved in Japan for recurrent or refractory primary central nervous system lymphoma

March 26, 2020

Dupixent approved for additional indication of chronic rhinosinusitis with nasal polyp

March 26, 2020

Intravitreal Eylea approved for neovascular glaucoma

March 26, 2020
Hand holding FDA blocks

Test developers frustrated by FDA’s resistance to at-home testing

March 25, 2020
By Mark McCarty
The surge of interest in testing for the COVID-19 pathogen has led to some innovative tests and test strategies, including at-home tests. However, the FDA has indicated that it is wary of both at-home testing and specimen collection in other than supervised settings, a policy that is meeting with criticism from some quarters, but not all.
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