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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...

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.

Endo Wants Generic Epinephrine Restrictions

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Endo asks FDA not to receive or approve any applications for a generic form of Endos epinephrine products that do not refer to the...

Vaccine Skeptic Kennedy Confirmed as HHS Secretary

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The U.S. Senate votes 52-48 to confirm vaccine skeptic Robert F. Kennedy Jr. to serve as the next HHS secretary.

Study Sees New Trazodone Adverse Events

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Researchers in China say they found several new adverse event signals in their review of 20 years of FDA adverse event reports on ...

FDA Still Faster than EMA on Cancer Approvals

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A Friends of Cancer Research study update says FDA continues to review and approve novel cancer drugs faster than the European Med...

Sanofi/J&J Scrap E. Coli Vaccine Candidate

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Sanofi and Johnson & Johnson stop the development of their vaccine candidate for extraintestinal pathogenic E. coli because Phase ...