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Pull LASIK Off Market: Waxler

[ Price : $8.95]

Former CDRH branch chief Morris Waxler tells CBS News LASIK eye surgery should be pulled from the market due to complications.

Panel Nixes Lilly/Boehringer Diabetes Drug

[ Price : $8.95]

FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes to not recommend approval of Eli Lilly and Boehringer Ingelheims ...

Botanical Safety Consortium Convened

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FDA says the Botanical Safety Consortium has been formally convened under a memorandum of understanding between FDA and two resear...

FDA Approves BeiGenes Brukinsa for Some Lymphomas

[ Price : $8.95]

FDA approves BeiGenes Brukinsa capsules to treat some adults with mantle cell lymphoma.

Isorx FDA-483 Released

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FDA releases an FDA-483 with four inspection observations on an inspection at Isorx Corp.

NantHealth Tumor Mutational Burden Assay Cleared

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FDA clears a NantHealth 510(k) for its Omics Core, a whole exome tumor-normal in vitro diagnostic that measures overall tumor muta...

X4 Pharma Gains Breakthrough for Mavorixafor

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FDA grants X4 Pharmaceuticals a breakthrough therapy designation for mavorixafor for the treatment of adult patients with WHIM (Wa...

FDA Clinical Hold on Marker Leukemia Trial

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FDA places a clinical hold on a Marker Therapeutics planned Phase 2 study of its MultiTAA T-cell therapy in post-allogeneic hemato...

Revise Anti-Infective Drug Development Outcomes: Study

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Researchers call on FDA to update guidances on endpoints for developing anti-infective drugs.

Trump Changing Drug Price Plan

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The Hill reports the Trump administration is proposing to lower some drug prices by ensuring that prices in this country are lower...