FDA clears a DeepWell Digital Therapeutics 510(k) for its biofeedback software development kit for use in over-the-counter treatments to relieve stres...
Federal Register notice: FDA classifies whole exome sequencing devices into Class 2 (special controls).
Aisa Pharma wins an FDA orphan drug designation for its investigational drug AISA-021 (cilnidipine) and its use in treating systemic sclerosis.
Federal Register notice: FDA classifies blood collection devices for cell-free nucleic acids into Class 2.
GSK says data from two clinical trials showed that depemokimab significantly reduces asthma exacerbations in patients with severe Type 2 inflammation.
FDA removes a partial clinical hold against Rezolutes RZ358 (ersodetug), an investigational drug for treating hypoglycemia caused by congenital hyperi...
FDA clears a Femasys 510(k) for its diagnostic device for checking the fallopian tubes to confirm permanent birth control placement.
The Association for Diagnostics and Laboratory Medicine raises significant concerns regarding the recent FDA final rule on laboratory-developed tests,...
