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Compass Therapeutics Reports on Tovecimig Trial Data

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Compass Therapeutics reports statistically significant top-line data on the primary efficacy endpoint from its COMPANION-002 trial...

3 Observations on SKNV Outsourcing FDA-483

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FDA releases the form FDA-483 with three observations from an inspection at the Pompano Beach, FL-based SKNV outsourcing facility.

Multiple Violations in Next Science Inspection

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FDA warns Jacksonville, FL-based Next Science that it is illegally manufacturing and distributing adulterated and misbranded medic...

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...

Marks Firing Challenges RFK Jr.s Fitness for Office

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FDA Webview editor Jim Dickinson analyzes the firing of CBER director Peter Marks and finds it a challenge to HHS secretary and va...