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Medtronic Recalls Aortic Root Cannulas

[ Price : $8.95]

Medtronic recalls its Aortic Root Cannulas due to risks presented by unexpected loose material in the male luer used in the device...

Smallpox/Mpox Vaccine OKd Despite CBER Turmoil

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FDA approves Bavarian Nordics freeze-dried formulation of Jynneos smallpox and mpox vaccine despite concerns over CBER director Pe...

Vanda Files NDA for Antipsychotic Drug

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Vanda Pharmaceuticals files an NDA for Bysanti (milsaperidone) for treating acute Bipolar I disorder and schizophrenia.

Imfinzi Wins Approval for Bladder Cancer

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FDA approves AstraZenecas Imfinzi (durvalumab) for treating adults with muscle invasive bladder cancer.

Trump Order Stifles Union Representation at FDA

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President Trump signs an executive order to remove organized union representation from the majority of government agencies, includ...

Merck Touts Data in Pulmonary Arterial Hypertension

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Merck reports data from its Phase 3 ZENITH trial that showed Winrevair (sotatercept-csrk) significantly reduces the risk of major ...

FDA Clears TrainHealths Neuromuscular Stimulator

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FDA clears a TrainHealth 510(k) for its TrainFES neuromuscular stimulator and its use in treating people with sequelae of stroke a...

FDA Loses on Regulating Lab-Developed Tests

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Eastern Texas federal judge Sean Jordan rules against FDA in a case challenging the agencys final rule regulating laboratory-devel...

FDA Green Lights At-Home Sexual Disease Test

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FDA grants Visby Medical a de novo marketing clearance for its Womens Sexual Health Test, a non-prescription at-home diagnostic te...

Meeting on Opioid Postmarketing Studies Set for 5/5

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FDA reschedules for 5/4 a previously planned joint advisory committee meeting on studies that looked at the use of opioid analgesi...