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Positive Data on New Breast Cancer Drug

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BioNTech and Duality Biologics report that trastuzumab pamirtecan met its primary endpoint in a pivotal Phase 3 trial for patients...

Green List to Block Illegal GLP-1 Imports: FDA

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FDA unveils a new green list import alert aimed at preventing unapproved and potentially unsafe GLP-1 drug ingredients from enteri...

CERo Gets Fast Track for Leukemia Therapy

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FDA grants CERo Therapeutics fast track status for CER-1236 and its use for treating acute myeloid leukemia.

FDA Expert Panels Skirt Transparency Standards: Opinion

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Johns Hopkins drug safety expert G. Caleb Alexander says FDAs recent use of ad hoc expert panels in place of traditional advisory ...

FDA Probing Childrens Deaths from Covid Vaccine: Makary

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FDA commissioner Marty Makary says an evaluation of reports contained in the agencys vaccines adverse event database shows there h...

Pyrukynd sNDA Extended Due to REMS Review

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FDA extends by three months its review of Agios Pharmaceuticals supplemental NDA seeking to expand the use of Pyrukynd (mitapivat)...

FDA Says Lillys Olomorasib is Breakthrough Therapy

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FDA grants breakthrough therapy designation to Lillys oloromasib for certain lung cancers.

14 GenoGenix Inspection Observations

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FDA releases the form FDA-483 containing 14 observations from an inspection at the GenoGenix outsourcing facility in Boca Raton, F...

Sanofi Dermatitis Drug Meets Endpoints in Study

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Sanofi says its investigational antibody amlitelimab met all primary and key secondary endpoints in a late-stage trial of patients...

RFK Jr. Grilled at Heated Senate Hearing

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Bipartisan criticism of Health and Human Services secretary Robert F. Kennedy Jr. dominates a contentious three-hour Senate Financ...