The FDA granted accelerated approval to Bristol Myers Squibb’s oral iberdomide (marketed as Zenbexus) for multiple myeloma that has returned or become resistant, expanding the agency’s use of accelerated pathways in plasma-cell malignancies. The approval adds another oral option for later-line disease and reinforces ongoing demand for next-generation, mechanism-driven myeloma agents. Separately, European regulators detailed their skepticism of the data behind Amgen’s Tavneos and said they pulled the product from the market in Europe, citing concerns that were spelled out in regulator documents. The move highlights how real-world scrutiny and data substantiation can quickly change the accessibility of rare-disease therapies even after prior review steps.