FDA warns Lawrenceville, NJ-based EpiCare Acquisitions about Quality System and other violations in its manufacturing of a family of laser systems.
Bausch + Lomb recalls its enVista intraocular lenses after the company received reports of complications, which it says could not immediately be expla...
Six Sidley attorneys raise several practical questions arising from a Texas federal court decision finding that FDA does not have legal authority to r...
FDA grants Allogene Therapeutics three fast track designations for ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T cell therapy ...
A Senate HELP Committee postpones a hearing tentatively planned for 4/10 because HHS secretary Robert F. Kennedy, Jr. reportedly could not appear this...
Rhythm Pharmaceuticals announces positive topline results from the pivotal Phase 3 TRANSCEND trial evaluating setmelanotide for treating acquired hypo...
FDA accepts for review a Teva Pharmaceuticals supplemental BLA for Ajovy (fremanezumab-vfrm) to expand the indication to include preventing episodic m...
Former CDRH director Jeff Shuren says recent staff cuts at CDRH will likely lead to longer review times.