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BMS Reblozyl Meets Endpoint in Anemia Patients

[ Price : $8.95]

Bristol Myers Squibb reports that its COMMANDS Phase 3 study evaluating Reblozyl (luspatercept-aamt) met its primary endpoint in f...

FDA Helping Philips to Resolve MRI-related Shortages

[ Price : $8.95]

FDA recommends that health care providers discuss alternative magnetic resonance imaging-guided breast biopsy options with patient...

FDA Alert on Tracheostomy Tube Shortages

[ Price : $8.95]

FDA alerts patients and health care providers about a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufact...

510(k) Addresses FDA Hemodialysis Machine Concerns

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FDA clears a Fresenius Medical 510(k) to implement changes to its 2008T hemodialysis machines that addresses an earlier FDA safety...

FDA Rejects Gilead Hepatitis Delta BLA

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FDA issues Gilead a complete response letter on its BLA for bulevirtide, an investigational entry-inhibitor for treating adults wi...

C-Diff Drug Development Guide

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Federal Register notice: FDA makes available a draft guidance entitled Clostridioides difficile Infection: Developing Drugs for Tr...

4 Information Collections Approved by OMB

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Federal Register notice: FDA posts notifications that four information collections have been approved by OMB.

FDA Relaxes Promotion Restrictions on Covid EUAs

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FDA relaxes advertising and promotion restrictions placed on six Covid-19 emergency use authorizations.

Advanced Compounding Hit With FDA-483

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FDA posts a seven-item Form FDA-483 from an inspection of New England Life Care (dba Advanced Compounding Solutions) earlier this ...

Advisory Panel Shoots Down Y-mAbs BLA

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An FDA advisory committee unanimously votes to not recommend approval of a Y-mAbs Therapeutics BLA for I-omburtamab.