Edgewise Therapeutics says its EDG-7500 achieved positive results in the four-week CIRRUS-HCM trial in hypertrophic cardiomyopathy.
The Senate HELP Committee invites HHS secretary RFK, Jr., to testify on his reorganization of the department.
FDA misses its 4/1 user fee review action target date on a Novavax BLA seeking full approval for its current Covid-19 vaccine.
FDA says it is reprioritizing planned inspections for the rest of the year due to challenges it faces after 170 administrative and management staff we...
FDA clears a Medivis 510(k) for its Spine Navigation platform that uses augmented reality and artificial intelligence (AI) to assist surgeons in spina...
FDA warns Columbus, OH-based Rex Implants that it is illegally manufacturing and distributing three medical devices.
Bausch + Lomb recalls all enVista intraocular lenses due to increasing adverse event reports of toxic anterior segment syndrome associated with the de...
Axsome Therapeutics says its solriamfetol missed the primary endpoint in a Phase 3 proof-of-concept trial to treat major depressive disorder, but a pr...
