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A research study advocates for greater use of pharmacogenomic information in prescription drug labeling to aid the development of ...[ Price : $8.95]
FDA accepts for priority review a Seattle Genetics NDA for tucatinib for use in combination with trastuzumab and capecitabine for ...[ Price : $8.95]
FDA accepts for priority review a Bristol-Myers Squibb BLA for lisocabtagene maraleucel, an autologous anti-CD19 CAR T-cell immuno...[ Price : $8.95]
FDA approves an Orthofix Medical PMA for the STIM onTrack mobile app version 2.1 for use with the companys bone growth stimulators...[ Price : $8.95]
FDA classifies as Class 1 a Tytek Medical recall of its PneumoDart, a compact device used to remove air from the pleural cavity.[ Price : $8.95]
FDA says Eisai has submitted a request to voluntarily withdraw its Belviq weight-loss drug from the market after FDA found an incr...[ Price : $8.95]
CDER launches a Controlled Substances Program to coordinate Center activities and emerging issues around various controlled substa...[ Price : $8.95]
CDRH releases three new learning modules on aspects of the 510(k) third-party review program.