Regulatory Filings and Submissions

EC Grants Marketing Authorization for Remsima

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Celltrion Healthcare has announced in a July 27, 2020 press release, that the European Commission (EC) has granted marketing authorization for its subcutaneous (SC) formulation of Remsima (infliximab, CT-P13). Remsima SC is now approved for the treatment of adult patients with ankylosing s

FDA Maps Expectations for COVID Vaccine Proposals

With more than 100 vaccine research programs looking to address the pandemic, FDA officials are moving to clarify standards and requirements for vetting and approving viable preventives. The agency recently issued a lengthy guidance outlining recommendations for documenting vaccine quality,