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FDA Approves Viivs Apretude for HIV Pre-Exposure

[ Price : $8.95]

FDA approves Viivs Apretude injection for HIV pre-exposure prophylaxis.

Viona Recalls Metformin for NDMA Impurity

[ Price : $8.95]

Viona Pharmaceuticals recalls 33 lots of metformin HCl extended-release 750 mg tablets due to possible NDMA contamination.

New Xarelto Indication Approved

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FDA approves a new pediatric indication and new dosage form for Janssens Xarelto.

FDA Approves Xeris Biopharmas Recorlev

[ Price : $8.95]

FDA approves Xeris Biopharmas Recorlev for treating Cushings syndrome.

Eisai/Biogen Get Fast Track for Alzheimers Therapy

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FDA grants Eisai and Biogen a fast track designation for lecanemab, an investigational anti-amyloid beta protofibril antibody for ...

Fresenius Connect Infusion Cyber Alert

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FDA says the Cybersecurity and Infrastructure Security Agency has identified vulnerabilities in the Fresenius Kabi Agilia Connect ...

FDA Amends Pfizer Covid Vaccine EUA

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FDA amends the Pfizer/BioNTech vaccine EUA to allow booster shots for those ages 12 to 15 and a shorter period between primary and...

CDRH Hoping for Normal Review Times

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CDRH officials say they are working toward normal review times in FY 2022.

Covidien Class 1 Recall of Ventilator

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FDA classifies as Class 1 a recall by Medtronics Covidien unit of its Puritan Bennett 980 Ventilator Series System due to a manufa...

Court Orders End to Nano Silver Distribution

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The New Jersey federal court enters a consent decree of permanent injunction against Natural Solutions Foundation and its principa...