pharmaphorum2d
Class II approval revs up Huma’s SaMD platform
Huma Therapeutics has been granted Class II clearance from the FDA ... Device (SaMD) disease management platform, dramatically expanding the range of services it can deliver. Class II approval ...
BioPharma Dive11d
Federal watchdog cites concerns with FDA’s accelerated approval process
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
pharmaphorum8d
ResApp bags FDA okay for sleep apnoea app, after Pfizer takeover bid
has been approved by the FDA. Brisbane, Australia-based ResApp has claimed a 510(k) clearance for SleepCheckRx as a prescription-only digital therapy in the software-as-a-medical device (SaMD ...
Popular Science4d
FDA approves first-of-its-kind nasal spray for severe depression
The FDA fast-tracked Spravato’s approval through its Priority Review process after receiving results from a randomized, double-blind, placebo-controlled study of the medication. Volunteers were ...
FierceBiotech3d
FDA delays decision on Stealth's 2nd shot at approval for ultrarare disease med
An FDA advisory committee may have ruled in elamipretide’s favor back in October, but it looks like Stealth BioTherapeutics ...