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FDA Approves Novartis Cosentyx

[ Price : $8.95]

FDA approves Novartis Cosentyx to treat two forms of arthritis in some pediatric and adult patients.

Fast Track Designation for Lecanemab

[ Price : $8.95]

FDA grants fast track designation for BioArctic and Eisais early Alzheimers drug lecanemab.

FDA Approves Novartis Cholesterol Drug Leqvio

[ Price : $8.95]

FDA approves Novartis Leqvio to lower cholesterol in specified high-risk adults.

Patent License for Magnetic Resonance Spectroscopy

[ Price : $8.95]

Federal Register notice: FDA seeks comments on whether it should grant an exclusive patent license to Houston, TX-based Voxel Syst...

Arthroscopy Pump Tubing 510(k) Guidance

[ Price : $8.95]

FDA issues a guidance on 510(k) submissions for arthroscopy pump tubing sets intended for multiple patient use.

FDA Seeks Industry Organizations for Device Panels

[ Price : $8.95]

Federal Register notice: FDA seeks industry organizations interested in participating in selecting nonvoting industry representati...

FDA OKs Rezglovar Insulin Glargine Biosimilar

[ Price : $8.95]

FDA approves Lillys Rezvoglar insulin glargine biosimilar.

EUA for Roche Home Covid Rapid Test

[ Price : $8.95]

FDA approves an emergency use authorization for a Roche rapid at-home Covid-19 test.

Siemens Home Covid Test Gets EUA

[ Price : $8.95]

FDA gives an emergency use authorization to a Siemens at-home 15-minute Covid antigen test.

FDA Orphan Drug Designation for Silmitasertib

[ Price : $8.95]

FDA grants an additional orphan drug designation to Senhwa Biosciences silmitasertib, this time to treat patients with medulloblas...