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FDA OKs Expanded Indication for Reblozyl

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FDA approves a Bristol Myers Squibb BLA supplement for Reblozyl (luspatercept-aamt) for treating anemia in patients with very low-...

FDA Monitoring Social Media Drug Promotion: Post

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Two SheppardMullin attorneys say the second Warning Letter issued this year by the CDER Office of Prescription Drug Promotion show...

9 GA Congress Members Want Chemo Transparency

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A bipartisan group of nine members of Congress from Georgia calls for greater FDA transparency on efforts to resolve the current s...

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...