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 ...

Caliway Biopharmaceuticals (Caliway) announced that the subject recruitment of CBL-514 Phase 2b study for Dercum's disease (CBL-0202 DD Phase 2b study, NCT06303570) has been initiated. The study ...

Perineologic, a pioneer in transperineal prostate biopsy technology, is pleased to announce a strategic investment from a group of highly seasoned private equity and hedge fund executives. This ...

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 ...

The Food and Drug Administration (FDA) has begun an expert, independent review of recent research on the health effects caused by heavy metals in tampons after lawmakers sounded the alarm on ...

Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections in the U ...

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 ...