FDA grants Medtronic a breakthrough device designation for the Emprint ablation catheter kit, which is intended to be used in conjunction with the Emp...
FDA says it is concluding the Quality in 510(k) Review pilot program as of 5/30 and recommending that submitters make use of eSTAR instead.
Saniona says responding to an FDA request for Tesomet manufacturing information will delay the start of a Phase 2b trial.
FDA brings Erica Jefferson back to the agency as associate commissioner for external affairs.
FDA releases its latest batch of Warning Letters that include American Specialty Pharmacy and Exela Pharma Sciences.
FDA accepts for filing and grants priority review to Axsome Therapeutics AXS-05 to treat major depressive disorder.
Federal Register notice: FDA makes available a draft guidance entitled Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products f...
FDA lifts a clinical hold against Voyager Therapeutics and its planned clinical trial for VY-HTT01 for treating Huntingtons disease.