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FDA Alert on Boston Accolade Pacers Early Replacement

[ Price : $8.95]

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

Axsome Plans Alzheimers NDA on Mixed Data

[ Price : $8.95]

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

[ Price : $8.95]

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

Mylan 6-Item Form FDA-483 Posted

[ Price : $8.95]

FDA posts a six-item Form FDA-483 that led to a 12/19 Warning Letter to Mylan Laboratories citing its Pradesh, India manufacturing...

FDA Approves Xcoverys Ensacove for Some Lung Cancers

[ Price : $8.95]

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.

CRL for Zealands SBS Treatment NDA

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FDA issues a complete response letter for Zealands glepaglutide intended to treat short bowel syndrome.

Quality, Data Issues at Mylan Facility in India

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FDA warns a Viatris Mylan drug manufacturing facility in Pradesh, India, about CGMP violations involving quality and data issues.

Boxed Warning for Veozah Liver Injury

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FDA adds a liver injury Boxed Warning to labeling for Astellas menopause hot flash drug Veozah.

Lexicon Dropping Zynquista After CRL

[ Price : $8.95]

Lexicon stops development of its diabetes drug Zynquista that received an FDA complete response letter.