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Baxter Recalls Novum IQ Syringe Pump

[ Price : $8.95]

Baxter recalls its Novum IQ large volume pump after becoming aware of the potential for underinfusion following use of the devices...

House Subcommittee Advances FDA Budget Bill

[ Price : $8.95]

A House Subcommittee markup votes along party lines to vote out and advance the agencys FY 2026 spending bill to the full committe...

FDA OKs Petition to Correct Phathom Patent Listing

[ Price : $8.95]

FDA approves a Phathom Pharmaceuticals citizen petition that corrects an agency Orange Book listing to recognize 10 years of new c...

Amneal Recalls Contaminated Tablets

[ Price : $8.95]

Amneal Pharmaceutical recalls three lots of sulfamethoxazole/trimethoprim tablets because they may exhibit black spots on their ta...

Arvinas Files NDA for Breast Cancer Drug

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Arvinas files an NDA for vepdegestrant for treating patients with estrogen receptor-positive human epidermal growth factor recepto...

FDA: Draeger Recall is Class 1

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FDA says a Draeger recall of breathing circuit components is Class 1.

ICH M11 Technical Specification Guidance Out

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FDA publishes the International Council on Harmonization technical representation of its M11 guideline protocol template.

House Posts FDA Budget Mirroring Trumps Proposal

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The House Appropriations Committee posts FDAs budget bill for FY 2026 that mirrors the Trump Administrations budget proposal that ...

FDA Platform Technology OK for Sarepta Vector

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FDA grants platform technology designation to a Sarepta viral vector used in an investigational gene therapy to treat a form of mu...

New Safety-Related Hernia Mesh Label Recommendations

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FDA posts a draft guidance entitled Hernia Mesh Package Labeling Recommendations.