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Pharmacogenetic Info Helps Precision Medicine

[ Price : $8.95]

A research study advocates for greater use of pharmacogenomic information in prescription drug labeling to aid the development of ...

Seattle Genetics NDA for Tucatinib in Breast Cancer

[ Price : $8.95]

FDA accepts for priority review a Seattle Genetics NDA for tucatinib for use in combination with trastuzumab and capecitabine for ...

BMS BLA for B-cell Lymphoma Therapy

[ Price : $8.95]

FDA accepts for priority review a Bristol-Myers Squibb BLA for lisocabtagene maraleucel, an autologous anti-CD19 CAR T-cell immuno...

Orthofix Medical STIM onTrack Mobile App OKd

[ 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...

Tytek Medical Recalls PneumoDart

[ 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.

FDA Asks Eisai to Withdraw Belviq from Market

[ 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...

CDER Launches Controlled Substances Program

[ Price : $8.95]

CDER launches a Controlled Substances Program to coordinate Center activities and emerging issues around various controlled substa...

New 510(k) Review Learning Modules

[ Price : $8.95]

CDRH releases three new learning modules on aspects of the 510(k) third-party review program.

Workshop on DNA-based Cancer Screening Tests

[ Price : $8.95]

FDA announces a 3/9 workshop on Detecting Circulating Tumor DNA for Cancer Screening.

Medtronic MiniMed Pump Recall is Class 1

[ Price : $8.95]

FDA says the Medtronic recall of its MiniMed 600 Series insulin pumps, due to a missing or broken retainer ring, is Class 1.