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FDA Accepts Mirati Adagrasib NDA

[ Price : $8.95]

FDA accepts a Mirati NDA for adagrasib to treat some lung cancers.

CGMP Deviations at Indiana Chem-Port

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FDA warns Indias Indiana Chem-Port about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

Avila Herbals Did Not Follow Trial Rules: FDA

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FDA warns Christiansburg, VA-based Avila Herbals about concerns in its work as a clinical investigator of an investigational drug.

Comments Sought on WHO Drug Scheduling

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Federal Register notice: FDA seeks comments on recommendations by the World Health Organization to impose international manufactur...

Clinical Hold on Legend Bio CAR-T Therapy

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FDA places a clinical hold against Legend Biotech and its Phase 1 clinical trial for LB1901, an investigational autologous CAR-T c...

Califf Confirmed by Senate in Slim-margin Vote

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The U.S. Senate votes 50 to 46 to confirm Robert Califf as the next FDA commissioner.

FDA Could Improve Device Security: Expert

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Aspen Tech Policy Hub fellow Daniel Bardenstein says FDA should require medical device manufacturers to meet a baseline of cyberse...

FDA Clears Skin Observation Camera/Scope

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FDA clears a Casio America 510(k) for the DZ-D100 DermoCamera and the DZ-S50 scope for skin observation by dermatologists.

Motus GI Gets New Colonoscopy Device Cleared

[ Price : $8.95]

FDA clears a Motus GI Holdings 510(k) for the Pure-Vu EVS System for colonoscopies.

Prostate Cancer Blood Test Gets Breakthrough Status

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FDA grants Datar Cancer Genetics a breakthrough device designation for its TriNetra-Prostate blood test to detect early-stage pros...