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Cardinal Health Monoject Inspection Violations

[ Price : $8.95]

FDA warns Cardinal Health it is distributing unapproved medical devices that also have a Quality System Regulation violation.

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...

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.

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Boehringer Ingelheim suggests several modifications to an FDA draft guidance on key information and facilitating understanding in ...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FDA publishes a draft guidance with questions and answers on promotional communications for some prescription biologics.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

Amneal Generic OTC Narcan Spray OKd

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FDA approves an Amneal Pharmaceuticals ANDA for a generic over-the-counter naloxone hydrochloride nasal spray, 4mg, (generic Narca...

Cut Ozempic/Wegovy Price: HELP Committee

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Sen. Bernie Sanders and the HELP Committee call on Novo Nordisk to significantly reduce the cost of its Ozempic and Wegovy in the ...

Curio Postpartum Depression Device Cleared

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