J&J reports data from the Phase 2b SunRISe-1 study evaluating TAR-200, an intravesical gemcitabine releasing system, for patients with certain types o...
Novavax and HHS clarify that FDA is requesting a post-approval study and not a clinical trial that must be conducted prior to approval of the companys...
Medtronic files a PMA for its Hugo robotic-assisted surgery system for a urologic indication.
FDA clears BlackfinBio to conduct a Phase 1/2 clinical trial of its novel adeno-associated virus gene therapy, BFB-101, in children with hereditary sp...
FDA issues Telix Pharmaceuticals a complete response letter on its NDA for Pixclara (floretyrosine F18), a positron emission tomography agent for imag...
FDA issues a clinical hold on VYNE Therapeutics Phase 1b study evaluating VYN202 for treating moderate-to-severe plaque psoriasis based on testicular ...
HHS secretary Robert F. Kennedy Jr. vows to restore FDAs and other health agencies Freedom of Information Act (FOIA) offices that were gutted earlier ...
FDA grants Orchestra BioMed a breakthrough device designation for its atrioventricular interval modulation therapy that uses a pacemaker to reduce blo...
