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CGMP Violations in Spartan Chemical Inspection

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FDA warns Maumee, OH,-based Spartan Chemical Company about CGMP violations in its production of misbranded unapproved new drugs.

Taro Recalls Clobetasol Propionate Ointment

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Taro recalls one lot of clobetasol propionate ointment due to microbial contamination

2 Medical Device Covid Transition Plans

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FDA grants an additional orphan drug designation to Senhwa Biosciences silmitasertib, this time to treat patients with medulloblas...

Philips CavaClear Sheath Authorized

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FDA authorizes marketing of the Philips CavaClear Laser Sheath to assist in removing some inferior vena cava filters.

FDA Approves Viivs Apretude for HIV Pre-Exposure

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

Viona Recalls Metformin for NDMA Impurity

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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

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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 ...