At least 3 years before marketing authorisation, register on UK PharmaScan and keep your details updated. 2 to 5 years before marketing authorisation, request Integrated Scientific Advice, ideally ...

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

The FDA has released draft guidance outlining an approval pathway for individualized therapies aimed at ultra-rare diseases, building on a framework first outlined by agency leaders in November. The ...

Jason Mast is a general assignment reporter at STAT focused on the science behind new medicines and the systems and people that decide whether that science ever reaches patients. You can reach Jason ...

Compass Pathways has announced that its investigational psilocybin treatment has successfully met its primary endpoint in a second Phase 3 clinical trial moving it one step closer to FDA submission.

LONDON & NEW YORK--(BUSINESS WIRE)--Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced today the pricing of ...

Phase 3 clinical trial data has been a success. COMP360 is the first traditional psychedelic to consistently deliver a highly statistically significant outcome. Results included maintaining a ...

Painting Pathways Clubhouse in Manitowoc has appointed Gabriella Thiel as its new interim director. Thiel previously served as the organization's clubhouse coordinator and was unanimously supported by ...

OWENS CROSS ROADS, Ala. (WAFF) - Lawyers for a troubled teen facility in Owens Cross Roads are now responding to a lawsuit filed by the city. Pathway has been the center of scrutiny and controversy ...

The NFL has announced its International Player Pathway (IPP) program Class of 2026, featuring 13 athletes representing 10 nations around the world. Established in 2017, the IPP program identifies ...

UCSF is preparing to accept its latest batch of trainees as part of a $14 million workforce-development initiative for young San Francisco adults. Michael Jones, the program director at Career ...

GameSpot may get a commission from retail offers. Path of Exile 2 is playable now in early access, but the game's 1.0 release isn't ready yet--and it won't be here soon, it seems. Grinding Gear game ...