FDA grants Immedica Pharma an accelerated approval for its BLA for Loargys (pegzilarginase-nbln), the first therapy specifically designed to lower pla...
FDA issues Beta Bionics a Warning Letter, citing wide-ranging quality system, complaint handling, reporting, and recall-related violations tied to the...
BioMarin decides to voluntarily withdraw from the market its Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for treating adults with severe ...
AdvaMed urges federal health officials to keep FDA at the center of oversight for artificial intelligence tools used in patient care, warning that new...
FDA issues a Warning Letter to A. Nelson & Co. Ltd., citing significant current good manufacturing practice violations and raising concerns about micr...
Johnson & Johnson files a supplemental BLA seeking approval of Imaavy as a treatment for warm autoimmune hemolytic anemia.
FDA issues a draft guidance entitled Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target S...
FDA approves AstraZenecas Calquence (acalabrutinib) for use in combination with AbbVie and Genentechs Venclexta (venetoclax), a chemotherapy-free regi...
