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Human Drugs

BMS Reblozyl Meets Endpoint in Anemia Patients

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

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Medical Devices

FDA Helping Philips to Resolve MRI-related Shortages

FDA recommends that health care providers discuss alternative magnetic resonance imaging-guided breast biopsy options with patients if facilities are ...

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Medical Devices

FDA Alert on Tracheostomy Tube Shortages

FDA alerts patients and health care providers about a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufactured by ICU Medical....

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Federal Register

Special Protocol Assessment Information Collection

Federal Register notice: FDA seeks comments on an information collection extension entitled Special Protocol Assessment.

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Federal Register

Info Collection on BLA Procedures

Federal Register notice: FDA seeks comments on an information collection extension entitled Biologics License Applications Procedures and Requirements...

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Human Drugs

Measuring Growth and Evaluating Pubertal Development Guide

FDA posts a draft guidance on recommendations for measuring and recording growth, and evaluating pubertal development for evaluating safety in pediatr...

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Federal Register

Special Protocol Assessment Information Collection

Federal Register notice: FDA seeks comments on an information collection extension entitled Special Protocol Assessment.

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Biologics

FDA Rejects Gilead Hepatitis Delta BLA

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

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Federal Register

C-Diff Drug Development Guide

Federal Register notice: FDA makes available a draft guidance entitled Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction o...

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Federal Register

4 Information Collections Approved by OMB

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