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.
FDA approves an Amgen supplemental BLA for Uplizna (inebilizumab-cdon) for treating adults living with immunoglobulin G4-related disease.