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...
Compass Therapeutics reports statistically significant top-line data on the primary efficacy endpoint from its COMPANION-002 trial, an ongoing Phase 2...
FDA releases the form FDA-483 with three observations from an inspection at the Pompano Beach, FL-based SKNV outsourcing facility.
