News

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths
Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...
Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths
The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Ele­vidys, after three patients died from ...
Medical Device Network on MSN2d
UroMems awarded FDA IDE to use artificial urinary sphincter in pivotal trial
FDA's IDE approval for UroMems’ UroActive System follows strong feasibility clinical study results in both men and women.
Endocrinology Advisor3d
OTC Cuffless Blood Pressure Monitoring Device Gets FDA Clearance
The FDA has cleared the Hilo Band (G0 Blood Pressure Monitoring System) for at-home blood pressure monitoring in adults.