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FDA Promotes Dose Optimization Innovation: Report

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FDA researchers say the agency is working collaboratively to find innovative approaches to optimizing dosages of cancer drugs.

Texas Approves Drug Import Plan

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Texas approves a bill to create a program to import drugs from Canada pending HHS approval.

Lawmakers Ask FDA to Fix Orange Book Loopholes

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Senator Elizabeth Warren (D-MA) and Rep. Pramila Jayapal (D-WA) urge FDA commissioner Robert Califf to restrict patents that are l...

ICU Medical Infusion Pump Cleared

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FDA clears an ICU Medical 510(k) for the Plum Duo infusion pump with LifeShield infusion safety software.

Info Collection on FDA Surveys

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Federal Register notice: FDA sends to OMB an information collection extension entitled Customer/Partner Service Satisfaction Surve...

FDA OKs 15 Vyvanse Generics

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FDA approves 15 ANDAs representing the first generics of Takedas Vyvanse (lisdexamfetamine dimesylate) capsules and chewable table...

Janssen Files sBLA for Expanded Rybrevant

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Janssen Pharmaceutical files a supplemental BLA seeking an expanded approval for Rybrevant (amivantamab-vmjw) combination use wit...

Boston Scientific Positive Ablation Study

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Boston Scientific reports positive 12-month results from its pivotal ADVENT clinical trial of the FaraPulse Pulsed Field Ablation ...

Data Integrity Issues at Synapse Labs: Petition

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A Flag Pharma citizen petition asks FDA to revisit the therapeutic equivalence ratings of generic drug products that relied on bio...

FDA Clears BioProtect Balloon Implant

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FDA clears a BioProtect 510(k) for its BioProtect Balloon Implant System, a next-generation spacer designed to provide protection ...