See the latest news and media coverage for Sedana. We track all announcements, press releases, and industry mentions in real time, all in one place.
Medtech and pharmaceutical company focused on inhaled sedation
sedanamedical.comLast updated
In short: Sedana advanced its U.S. commercialization plans as the FDA accepted its New Drug Application with a PDUFA deadline of April 16, 2027.
The FDA accepted the NDA for isoflurane via the ACD Delivery System. This milestone follows pivotal trials showing reduced opioid use and a favorable safety profile.
Net sales were flat but EBITDA improved from -8% to -4%, and cash flow from operations improved.
CEO Johannes Doll, CFO Mikael Haag, and CMO Peter Sackey will present on July 17, 2026, and answer questions.
It concerns isoflurane delivered via the Sedaconda ACD for ICU inhaled sedation. FDA filing review and acceptance decision are expected in about two months.
The Food and Drug Administration has set April 16, 2027 as the expected deadline for the review of the company's authorization application for...
Surgical Science surges 23% after strong quarterly results while Xspray Pharma falls sharply on negative FDA news.
Sedana Medical AB (publ) is a Sweden-based medical technology company. It develops, markets and sales medical devices and conducts drug development for future projects around...
Sedana Medical, active in inhalation sedation, reports an operating result of minus 9.4 million kronor for the second quarter of 2026 (minus 9.5).
Track Sedana and your other target companies to get real-time alerts and weekly summaries delivered straight to your inbox.
Discover what's making headlines across other trending companies.