Orexo submitted vorvida for approval by the FDA in March, before the pandemic gathered pace in the US, and had been hoping for a third-quarter approval before the new pathway came into effect.

Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), today announces that the company has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding the New Drug ...

Swedish drugmaker Orexo, best known for its opioid addiction ... The regulatory climate is also much better for digital therapies, with the FDA developing standard review protocols and even ...

Medscape Medical News, July 17, 2024 US FDA Declines to Approve Orexo's Opioid Overdose Drug The U.S. Food and Drug Administration (FDA) has declined to approve Orexo AB's high-dose prescription ...

UPPSALA, Sweden, Sept. 3, 2024 /PRNewswire/ -- Orexo AB (Publ.), (STO: ORX) (OTCQX: ORXOY), today announces the company will participate in Pareto Securities' 15 th Annual Healthcare Conference ...

According to the FDA's approval notice, the Apple Watch sleep apnea function is not a diagnostic tool, but rather an over-the-counter device designed to assess watch-wearers' risk of sleep apnea.

Apple AirPods Pro 2 can soon be used as hearing aids, after they received Food and Drug Administration (FDA) clearance, in what experts call a game changer for the hearing aid market. The FDA on ...

The firms that are overdue for safety and quality inspections represent about 42% of the 4,700 plants that are currently registered to produce drugs for the U.S. and previously underwent FDA ...

Women won’t see any changes to their routine mammograms. The new FDA rule will be seen in their results. In addition to finding out whether cancer was detected or not, women will also be able to ...