The U.S. FDA's draft guidance for labeling and patient information for breast implants addresses concerns over anaplastic large cell lymphoma, but the draft also recommends biennial examination via ultrasound or MRI after five years, a recommendation that could prove a boon to makers of these imaging systems.
HONG KONG - China and U.S.-based I-Mab Biopharma Co Ltd. has won two IND clearances for TJ-202/MOR-202 from China's National Medical Products Administration (NMPA).
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