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Human Drugs

Foreign Free-Riding on U.S. Drug Investment Up: Report

The White House Council of Economic Advisers says the U.S. has paid more than its fair share for drug development and innovation because other countri...

Human Drugs

Pharmacogenetic Info Helps Precision Medicine

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

Human Drugs

Seattle Genetics NDA for Tucatinib in Breast Cancer

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

Biologics

BMS BLA for B-cell Lymphoma Therapy

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

Medical Devices

Orthofix Medical STIM onTrack Mobile App OKd

FDA approves an Orthofix Medical PMA for the STIM onTrack mobile app version 2.1 for use with the companys bone growth stimulators.

Medical Devices

Tytek Medical Recalls PneumoDart

FDA classifies as Class 1 a Tytek Medical recall of its PneumoDart, a compact device used to remove air from the pleural cavity.

Human Drugs

FDA Asks Eisai to Withdraw Belviq from Market

FDA says Eisai has submitted a request to voluntarily withdraw its Belviq weight-loss drug from the market after FDA found an increased risk of cancer...

Human Drugs

Man Sentenced to 7 Years Over Unapproved Drug

Florida federal judge Paul G. Byron sentences Barry Clint Wright (Monroe, NC) to seven years in federal prison for introducing an unapproved and misbr...

FDA General

FDA Justifies FY 2021 $6.2 Billion Budget Request

FDA sends Congress its justification for a $6.2 billion FY 2021 budget request.

Human Drugs

FTC Sues 2 Companies Over Joint Pain Products

The Federal Trade Commission sues two companies to stop them from falsely claiming that their pills are scientifically proven to alleviate joint pain ...