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Bhargava Phytolab CGMP Violations

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FDA warns Indias Bhargava Phytolab about CGMP issues in its manufacturing of finished drugs and active pharmaceutical ingredients....

QS, MDR Violations at Rontis Hellas in Greece

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FDA warns Greeces Rontis Hellas about Quality System and Medical Device Reporting violations in its production of a balloon cathet...

FDA Approves BMS Opdivo Qvantig Injection

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FDA approves Bristol Myers Squibbs Opdivo Qvantig subcutaneous injection for several cancer indications.

CGMP Violations in Micro Orgo Chem Inspection

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FDA warns Indias Micro Orgo Chem about CGMP deviations in its production of active pharmaceutical ingredients.

FDA Alert on Boston Accolade Pacers Early Replacement

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FDA alerts patients, caregivers, and healthcare providers to the potential for some Boston Scientific Accolade pacemakers to need ...

FDA Approves Xcoverys Ensacove for Some Lung Cancers

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FDA approves Xcoverys Ensacove, an anaplastic lymphoma kinase inhibitor, to treat some non-small cell lung cancers.

FDA Approves Humacytes Symvess

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FDA approves Humacytes Symvess for use with some extremity arterial injuries.

FDA Approves Checkpoints Unloxcyt

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FDA approves Checkpoint Therapeutics Unloxcyt to treat some squamous cell cancer patients.

Axsome Plans Alzheimers NDA on Mixed Data

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Axsome Therapeutics plans an NDA submission for AXS-05 (dextromethorphan-bupropion) in the second half of next year for treating A...

Exclude Liraglutide from Compounding: Novo Nordisk

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Novo Nordisk petitions FDA to exclude its liraglutide from the agencys list of bulk drug substances that may be used by drug compo...