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Jazz Pharma Hypersomnia Drug Approved

[ Price : $8.95]

FDA approves a Jazz Pharmaceuticals NDA for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for treating ...

Clinical Hold on Bluebird Bio Gene Therapy

[ Price : $8.95]

FDA places a clinical hold on Bluebird Bios Lenti-D (elivaldogene autotemcel) after the company reported a suspected unexpected se...

Comments Sought on Pre-Hatch-Waxman ANDAs

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Federal Register notice: FDA solicits comments on several issues related to FDAs post-approval regulation of certain drug products...

Baxter Recalls Infusion Pump Dosing Software

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Baxter Healthcare recalls its Dose IQ Safety Software used with the Spectrum IQ Infusion System due to a software defect.

Breakthrough Granted to Nasopharyngeal Carcinoma Drug

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FDA grants a breakthrough therapy designation to Shanghai Junshi Biosciences and Coherus BioSciences for toripalimab in combinatio...

FDA or Courts Should Rethink Off-Label Rules: Cato

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The Cato Institute says if FDA wont resolve its conflicting stance over off-label use and promotion, the courts should do so.

Vifor Asks FDA to Reverse Some Venofer Actions

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Vifor asks FDA to take specific steps to stay actions the agency took in a 2020 citizen petition response purporting to change the...

Patient Engagement Panel on Device Recalls

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Federal Register notice: FDA announces a 10/6 Patient Engagement Advisory Committee meeting that will discuss and make recommendat...

FDA Wants More Study of FibroGen Roxadustat

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An FDA complete response letter asks FibroGen to conduct additional roxadustat clinical studies before resubmitting its NDA.

FDA Says Vivera Selling Adulterated, Misbranded Covid Tests

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FDA warns Vivera Pharmaceuticals it is marketing unapproved, adulterated, and misbranded Covid-19 tests.