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Curio Postpartum Depression Device Cleared

[ Price : $8.95]

FDA clears a Curio Digital Therapeutics 510(k) for its MamaLift Plus, a prescription digital therapeutic for treating postpartum d...

Zydus Lifesciences Issued Another FDA-483

[ Price : $8.95]

An FDA inspection at Zydus Lifesciences injectable manufacturing site in Jarod, India results in a 10-observation Form FDA-483, th...

Dr. Reddys Recalls Sapropterin Dihydrochloride

[ Price : $8.95]

Dr. Reddys Laboratories recalls six lots of sapropterin dihydrochloride powder for oral solution 100 mg due to decreased potency. ...

Pivya Approved for Uncomplicated UTIs

[ Price : $8.95]

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

Priority Review for Jemperli sBLA

[ Price : $8.95]

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Boehringer Ingelheim suggests several modifications to an FDA draft guidance on key information and facilitating understanding in ...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FDA publishes a draft guidance with questions and answers on promotional communications for some prescription biologics.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

[ Price : $8.95]

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...