PR Newswire

The newsfeed available here is provided by our content partner PR Newswire. This is one of the most important and widest-reaching press services, providing news, press releases and multimedia content to the media, journalists and the public.
The NewsWire Hub ("X-Billboard") currently comprises four of the most important international news sources and is supplemented by a stock market information service. The individual newswire services complement each other and provide a complementary range of information, more than three quarters of the official news sources on which editors worldwide base their stock market reporting. Your advantage: You will find everything here in one overview. You can navigate to the individual sections using the control elements. In the terminal view, you can carry out individual searches at company level.
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PR Newswire is an important news source that can be accessed via the X-Billboard. It is part of the Newswire Hub, which bundles important international news sources for stock market participants in one central location. If you want to get a quick overview, you can easily scroll through the headlines. If you want to look at the news in more detail, you can use the detailed views of the info cards to directly access the respective news item and other analysis tools.
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State: 24.04.2025 | 11PM
Thu, 27.02.2025       Swedish Orphan Biovitrum
SE0000872095

STOCKHOLM, Feb. 27, 2025 /PRNewswire/ -- Sobi® (STO: SOBI), today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Gamifant® (emapalumab-Izsg) for use in adult and paediatric patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in Still's disease with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS. The application was granted Priority Review with a PDUFA date of June 27, 2025.

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The information provided here is not subject to any editorial processing. It is prepared fully automatically and enriched with additional information and further research options. The aim of the content is to provide information seekers with the relevant information quickly and easily. A link back to the information provider and owner ensures that the data prepared here can be compared with the source information if required. The newsboard does not show information in real time. Please contact the exchange operator for this information if required. There is no claim to completeness. High availability cannot be guaranteed. If you notice any errors in the functionality, please let us know using the "Report a Bug" form below.

RAW DATA PROCESSING means that raw data is processed without changing the content. The data is supplemented to improve the interpretation of the information in terms of usability.

Note: The newswire cross-link panel at the top allows you to quickly and easily access additional sources of information. In the terminal view, the news is filtered at company level and enables targeted searches.

On behalf of the trading community, we would like to thank the operators of the trading venues for providing information services.