Pfizer says the pivotal Phase 3 CREST trial of sasanlimab in combination with standard of care met its primary endpoint as an induction therapy with o...
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...
Former FDA commissioner Scott Gottlieb says FDA is likely to see up to a 25% reviewer exodus over the coming months as about 600 reviewers have curren...
A new biosimilars report says that FDA has approved a total of 73 biosimilars across 19 unique biological molecules, and so far only 48 (66%) of these...
