Several biotech companies face regulatory challenges as the FDA and authorities grapple with resource limitations amid a government funding lapse. Fortress Biotech received a Complete Response Letter for its Menkes disease treatment CUTX-101 due to manufacturing deficiencies, delaying approval. Cellectar Biosciences regained Nasdaq compliance after prior notices. Meanwhile, Rocket Pharmaceuticals withdrew its biologics license application for a rare bone marrow disorder gene therapy, prioritizing programs with clearer approval pathways. Additionally, CMS postponed decisions on drug price negotiation policies. These regulatory dynamics underscore ongoing hurdles in advancing therapies for rare diseases amid complex administrative landscapes.