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Device Color Additive Risk Calculator Qualified

[ Price : $8.95]

CDRH qualifies the CHemical RISk calculator Color Additives under its Medical Device Development Tools program.

2nd Alzheimers Therapy Death Raises Questions: Journal

[ Price : $8.95]

The journal Science says safety questions are being raised about Eisai and Biogens lecanemab (BAN2401), an investigational anti-am...

FDA Rejects Spectrum's Lung Cancer Drug

[ Price : $8.95]

FDA sends Spectrum Pharmaceuticals a complete response letter rejecting the companys poziotinib and its use in treating certain pa...

Panel to Discuss Regenerons Aflibercept Pediatric Use

[ Price : $8.95]

Federal Register notice: FDA announces a 1/9 Dermatologic and Ophthalmic Drugs Advisory Committee meeting to discuss a Regeneron P...

EUA for Lucira Covid-19 and Flu Test

[ Price : $8.95]

FDA approves an emergency use authorization for the Lucira Covid-19 and Flu Test.

Priority Voucher Used on AbbVies Skyrizi

[ Price : $8.95]

Federal Register notice: FDA announces that a priority review voucher was redeemed 6/16 by AbbVie for a supplemental BLA for Skyri...

FDA Waives Panel Meeting on Biomarin Gene Therapy

[ Price : $8.95]

FDA tells BioMarin Pharmaceutical that it no longer plans to hold an advisory committee meeting to review the companys resubmitted...

WatchCare Incontinence Management System Recall Class 1

[ Price : $8.95]

FDA says the Baxter Hillrom recall of WatchCare Incontinence Management Systems is Class 1.

Luer-Activated Valve Connector FDA Alert

[ Price : $8.95]

FDA alerts healthcare professionals about potential compatibility issues with prefilled glass syringes and certain Luer-activated ...

CDER Proposes to Withdraw Bufferin NDA

[ Price : $8.95]

Federal Register notice: CDER proposes to withdraw the approval of an NDA 006499 for Bufferin (aspirin) tablets because it has not...