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Medical Devices

Firm Pays $40 Million Over Adulterated Gowns

Kimberly-Clark agrees to pay $40 million under a deferred prosecution agreement to resolve a criminal charge that it sold adulterated MicroCool surgic...

FDA General

Gottlieb Warns HHS Could Undermine Pediatric Vaccines

Former FDA commissioner Scott Gottlieb warns that HHS secretary Robert F. Kennedy Jr. may attempt to use a forthcoming HHS report on autism to challen...

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Human Drugs

FDA Guidance on Good Clinical Practice Principles

FDA issues an updated guidance entitled E6(R3) Good Clinical Practice (GCP) that describes GCP principles, emphasizing flexible, modern approaches to ...

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Human Drugs

Lillys Jaypirca Shows Major Benefit in Leukemia Trial

New trial data show Eli Lillys Jaypirca (pirtobrutinib) significantly extended progression-free survival in previously untreated patients with chronic...

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Human Drugs

Merck Reports Favorable Lung Cancer Drug Data

Merck reports favorable results from the IDeate-Lung01 Phase 2 trial showing that ifinatamab deruxtecan demonstrated clinically meaningful response ra...

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Human Drugs

Complete Response on Saol Therapeutics NDA

FDA issues Saol Therapeutics a complete response letter on its NDA for SL1009 (sodium dichloroacetate oral solution) for treating pediatric Pyruvate D...

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Human Drugs

Green List to Block Illegal GLP-1 Imports: FDA

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

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Human Drugs

CERo Gets Fast Track for Leukemia Therapy

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

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Human Drugs

FDA Expert Panels Skirt Transparency Standards: Opinion

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

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Human Drugs

FDA Probing Childrens Deaths from Covid Vaccine: Makary

FDA commissioner Marty Makary says an evaluation of reports contained in the agencys vaccines adverse event database shows there have been Covid-19 va...