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...
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 ...
