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Gender Statement Added to Restored FDA Pages

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The Trump administration adds a gender ideology statement to two Web pages on draft guidances that FDA was ordered by a federal ju...

BMS Reports Disappointing Data in Melanoma Trial

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Bristol Myers Squibb says a Phase 3 trial evaluating Opdualag (nivolumab and relatlimab-rmbw) for treating patients with completel...

ICU Medical Recalls Potassium Chloride Lot

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ICU Medical recalls one lot of potassium chloride injection bags packaged in cases indicating 20 mEq per bag due to a mislabeling ...

New Endpoint Option for Alcohol Use Disorder

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CDER posts a drug development qualifying tool to support treatments for alcohol use disorder products.

Clinical Hold on Moderna Norovirus Vaccine

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FDA places a clinical hold on a Phase 3 study evaluating Modernas trivalent vaccine against norovirus (mRNA-1403) after a case of ...

FDA OKs Sanofis Merilog, a Novolog Biosimilar

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FDA approves Sanofi-Aventis Merilog (insulin-aspart-szjj) as a biosimilar to Novo Nordisks Novolog (insulin aspart) for improving ...

Abiomed Recalls Impella Heart Pumps

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Abiomed recalls its Impella RP with SmartAssist and Impella RP Flex with SmartAssist heart pumps to update their use instructions ...

More Accelerated Approval Changes Needed: Kaiser

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The Kaiser Permanente healthcare system calls for FDA and congressional changes to improve the utility of the drug accelerated app...

Astellas Wins Revised Label for Izervay

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FDA approves an Astellas Pharma supplemental NDA for Izervay (avacincaptad pegol intravitreal solution) that revises the labeling ...

Petition Seeks FDA Leukeran Actions

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A Buchannan Ingersoll petition asks FDA to impose conditions on ANDAs for generic forms of the cancer drug Leukeran.