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FDA grants Lantheus Holdings and Point Biopharma Global a fast track designation for 177Lu-PNT2002 for treating metastatic castrat...[ Price : $8.95]
After a delay caused by an FDA 2021 inspection and Warning Letter, the agency approves Medtronics MiniMed 780G insulin pump.[ Price : $8.95]
bluebird bio files for priority review a BLA for lovotibeglogene autotemcel (lovo-cel), a gene therapy for patients with sickle ce...[ Price : $8.95]
Generic drug lobbying arm says FDAs draft guidance entitled Product-Specific Guidance (PSG) Meetings Between FDA and ANDA Applican...[ Price : $8.95]
FDA places a partial clinical hold on a Foghorn Therapeutics clinical study of FHD-609 in synovial sarcoma and SMARCB1-deleted tum...[ Price : $8.95]
FDA clears a Maxtec 510(k) for the MaxO2 ME+p, an oxygen monitor with integrated pressure monitoring intended for continuous patie...[ Price : $8.95]
Avanos Medical recalls its Avanos Ballard Access Closed Suction System with Y-Manifold or Elbow Manifold after receiving complaint...[ Price : $8.95]
FDA extends by three months its review of a Daiichi Sankyo NDA resubmisson for quizartinib in combination with chemotherapy for tr...