The new Prescription Drug User Fee Act (PDUFA) date for diazoxide choline extended-release (DCCR) is slated for 27 March 2025 ...

Soleno submitted the NDA to the FDA on June 27, 2024. The FDA accepted the NDA and granted Priority Review in August 2024. Diazoxide choline has been granted Breakthrough and Fast Track Designations ...

Soleno Therapeutics ( NASDAQ: SLNO) fell about 17% in premarket trading after the U.S. FDA extended the review period for its ...

Following the U.S. Food and Drug Administration extending the review period for the company's New Drug Application (NDA) for ...

The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application ...

Whales with a lot of money to spend have taken a noticeably bullish stance on Soleno Therapeutics. Looking at options history ...

Choline is a necessary nutrient that plays a ... It’s also much easier to ingest than tablets or capsules, which can be a big plus for those who have trouble swallowing pills.

An NDA for its lead candidate, DCCR (diazoxide choline) extended-release tablets, a once-daily oral tablet for the treatment of Prader-Willi syndrome (PWS) is currently under review by the FDA and ...

The FDA Review Division has determined that there does not appear to be a need for an advisory committee meeting at this time for the New Drug Application (NDA) for DCCR (diazoxide choline) ...

Related to B vitamins, choline is an essential compound in the body that is vital for brain health and cognitive function.

An NDA for its lead candidate, DCCR (diazoxide choline) extended-release tablets, a once-daily oral tablet for the treatment of Prader-Willi syndrome (PWS) is currently under review by the FDA and ...