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Quantitative Medicine Center of Excellence Created

[ Price : $8.95]

CDER creates a new Center of Excellence for Quantitative Medicine to advance therapeutic medical product development and inform re...

4 Information Collections Approved by OMB

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FDA posts a notification about four information collections that have been approved by OMB.

Medline Recalls Kits/Tray Over Sterility

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Medline Industries recalls certain kits, trays and packs in direct response to Nurse Assists 11/2023 recall of 0.9% sodium chlorid...

J&Js Opsynvi OKd for Pulmonary Hypertension

[ Price : $8.95]

FDA approves Johnson & Johnsons Opsynvi, a combination single tablet of macitentan and tadalafil for treating adults with pulmonar...

Regeneron Complete Response on Lymphoma BLA

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FDA sends Regeneron Pharmaceuticals two complete response letters on its BLA for odronextamab in relapsed/refractory follicular ly...

FDA Again Seeks Ban on Shock Devices

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Following recent Congressional action giving FDA additional authorities, the agency is again proposing a rule to ban electrical st...

GAO Report Hits FDA on Investigator Retention

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A new Government Accountability Office report says FDA needs to evaluate its recruitment and retention efforts to support and main...

Panel to Mull Minimal Residual Disease Endpoint

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Federal Register notice: FDA announces a 4/12 Oncologic Drugs Advisory Committee meeting to discuss the use of minimal residual di...

Arrow QuickFlash Radial Artery Catheter Recall

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Teleflex/Arrow International recalls the Arrow QuickFlash Radial Artery Catheterization Set (wire, guide, catheter) device due to ...

Italfarmaco Wins Approval for Duchenne Drug

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FDA approves Italfarmacos Duvyzat (givinostat), an oral drug for treating Duchenne Muscular Dystrophy in patients six years of age...