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Pivya Approved for Uncomplicated UTIs

[ Price : $8.95]

FDA approves Utility Therapeutics Pivya for some uncomplicated urinary tract infections.

Priority Review for Jemperli sBLA

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FDA accepts for priority review a GSK supplemental BLA for Jemperli (dostarlimab) for combination use with standard-of-care chemot...

Boehringer on Improving Informed Consent Guide

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Boehringer Ingelheim suggests several modifications to an FDA draft guidance on key information and facilitating understanding in ...

Biological Promotion Q&A Guidance

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FDA publishes a draft guidance with questions and answers on promotional communications for some prescription biologics.

State Lack of Fenofibrate CV Benefit: Petition

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The educational group Healthy Women petitions FDA to change fenofibrate labeling to state there is no proven cardiovascular benefi...

QS, MDR Issues at Royal Philips China Plant

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FDA warns Royal Philips about Quality System and Medical Device Reporting violations at its medical device manufacturing facility ...

Annual Report on Postmarketing Requirements

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Federal Register notice: FDA makes available its annual report entitled Report on the Performance of Drug and Biologics Firms in C...

Colon Cancer Blood Test Goes to Panel

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Federal Register notice: An FDA advisory committee schedules a 5/23 meeting to review a Guardant Health PMA for its Shield blood t...

PMRs and PMCs Generally on Schedule: FDA Report

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FDA says most applicants completed or released most of the premarketing requirements or commitments reported in the agencys FY 202...

Get Involved with FDA on AI/ML: Attorneys

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Three Alston Bird attorneys urge companies regulated by FDA to engage with the agency on issues involving artificial intelligence ...