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FDA approves an Eli Lilly BLA for Ebglyss (lebrikizumab-lbkz) for treating adults and children 12 years of age and older with mode...[ Price : $8.95]
FDA clears a SamanTree Medical 510(k) for its Histolog Scanner for imaging the internal microstructure of tissues including identi...[ Price : $8.95]
FDA approves Genentechs Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) twice-a-year subcutaneous injection for treating relap...[ Price : $8.95]
A group of bipartisan U.S. senators introduce the FDA Modernization Act 3.0, a bill to direct the agency to finally implement the ...[ Price : $8.95]
FDA seeks comments on the use of its Integrated Review document as it decides to expand its use beyond new molecular entities, ori...[ Price : $8.95]
Federal Register notice: FDA announces an 11/7 advisory committee meeting to review an IceCure Medical de novo request for its Pro...[ Price : $8.95]
FDA says it has added a Warning to labeling for Astellas Veozah about the risk of rare but serious liver injury.[ Price : $8.95]
A new National Academies book on collaboration in rare disease drug development lists steps it recommends that FDA take.