STOCKHOLM, Jan. 4, 2023 /PRNewswire/ -- Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the evaluation of isoflurane via the Sedaconda ACD-S device for sedation of mechanically ventilated patients in the intensive care (ICU) setting.
STOCKHOLM, April 28, 2022 /PRNewswire/ -- Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the first patient has been enrolled in the company's US clinical studies. The two identical Phase III studies, INSPiRE-ICU 1 and 2, aim to confirm the efficacy and safety of inhaled sedation with isoflurane delivered via Sedaconda ACD and are expected to lead to a new drug application (NDA) filing at the US Food and Drug Administration (FDA) in the US.
STOCKHOLM, Dec. 23, 2021 /PRNewswire/ -- 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 products in the United States.
STOCKHOLM, Dec. 23, 2021 /PRNewswire/ -- 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 products in the United States.
Sedana Medical AB (publ), a pioneer medtech and pharmaceutical company, 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 with its Sedaconda products in the United States.
STOCKHOLM, Nov. 24, 2021 /PRNewswire/ -- 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 with its Sedaconda products in the United States.
And the next person to hold the CEO post at Medivir is … Jens Lindberg. The AstraZeneca veteran will become the fourth person to hold the post, on an interim or permanent basis, in quick succession when he takes up the position.
Net sales totalled MSEK 40 (41), equivalent to a decrease of 2 percent compared to the second quarter of 2020. At constant exchange rates, sales increased by 3%. In May and June, we saw a slowdown in the third wave of the pandemic in Europe, while it is increasing in Latin America and other regions in our distributor markets.