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 ...
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 ...
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 ...