Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the company has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to initiate phase III pivotal clinical trials with its Sedaconda pro…
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the company has submitted an application for market approval for Sedaconda (isoflurane) for inhaled sedation in intensive care in Italy.
Regulatory
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO, THE UNITED STATES OF AMERICA, AUSTRALIA, HONG KONG, CANADA, NEW ZEALAND, JAPAN, SINGAPORE OR SOUTH AFRICA OR ANY OTHER JURISDICTION IN WHICH THE DI…
Regulatory
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO, THE UNITED STATES OF AMERICA, AUSTRALIA, HONG KONG, CANADA, NEW ZEALAND, JAPAN, SINGAPORE OR SOUTH AFRICA OR ANY OTHER JURISDICTION IN WHICH THE DI…
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the company has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA), with the aim to commence its phase III pivotal clinical trials…
Regulatory
Sedaconda (isoflurane) approved in 11 European markets
Regulatory
Sedana Medical AB (publ) today publish that in accordance with the resolution of the Annual General Meeting on May 10, 2021, the Chairman of the Board has contacted the company’s three largest shareholders or group of shareholders in terms of votes t…
Non-regulatory
Sedana Medical AB (publ) plans to present its interim report for the third quarter 2021 in an audiocast on November 4 at 13.30 CET.
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the company will hold a scientific symposium at ESICM Lives 2021, the annual congress of the European Society of Intensive Care Medicine. Additional data on inhaled sedation will al…
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has received market approval for inhaled sedation in Germany.
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company will host a symposium at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) in Brussels on August 31-September 3, 2021, where the full details…
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the results of the company's pivotal study Sedaconda (SED001) have been published in the highly ranked scientific journal, the Lancet Respiratory Medicine.
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has received market approval for inhaled sedation in France.
Non-regulatory
Sedana Medical AB will present its interim report for the second quarter 2021 in an audiocast on August 19 at 13.30 CEST.
Regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has received a positive outcome for its European registration application for the drug Sedaconda (isoflurane) for inhaled sedation. Sedaconda is indicated for sedation o…
Regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has completed a successful End of phase II meeting with the US Food and Drug Administration (FDA). The FDA accepted Sedana Medical's proposals for phase III program, inc…
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has received an approval for its quality system (QMS) according to the EU Medical Device Regulation (MDR) 2017/745. The approval means that Sedana Medical's Class I medi…
Non-regulatory
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company's pivotal phase III study Sedaconda (SED001) has been named one of the three best posters at the 52[nd] intensive care conference DGIIN & ÖGIAIN 16–18 June 2021.
Regulatory
At the annual general meeting of Sedana Medical AB (publ) (SEDANA: FN Stockholm) held May 10, 2021, it was resolved, in accordance with the board of directors' proposal, on a division of shares (split), whereby each current share is divided into four…