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Biologics

Novavax Amends Covid Vaccine EUA

Novavax files an amendment to its Emergency Use Authorization for an updated JN.1 Covid-19 vaccine (NVX-CoV2705) for individuals aged 12 and older.

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Human Drugs

Guide on Diabetic Foot Infection Drugs

FDA posts a final guidance entitled Diabetic Foot Infections (DFI): Developing Drugs for Treatment.

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Human Drugs

Amgens Blincyto Gets Expanded Leukemia Use

FDA approves an expanded use for Amgens Blincyto (blinatumomab) for treating adult and pediatric patients one month or older with lymphoblastic leukem...

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Biologics

Pfizer Duchene Gene Therapy Fails Phase 3 Study

Pfizer says that its Phase 3 CIFFREO placebo-controlled study evaluating an investigational mini-dystrophin gene therapy, fordadistrogene movaparvovec...

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Federal Register

Shaver Permanently Debarred by FDA

Federal Register notice: FDA issues an order permanently debarring Jonathan R. Shaver from providing services in any capacity to a person that has an ...

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Federal Register

FDA Debars Smith for 5 Years

Federal Register notice: FDA issues an order debarring Richard B. Smith III for five years from importing or offering for import any drug into the U.S...

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Human Drugs

Emerging Drug Safety Technology Meeting Program

CDER Office of Surveillance and Epidemiology deputy director Robert Ball describes the Emerging Drug Safety Technology Meeting program that offers acc...

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Human Drugs

DSCSA Pilot Project Report Out

FDA says it has issued a final report from the Drug Supply Chain Security Act pilot project.

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Human Drugs

ICH M10 Bioanalytical Method Analysis Q&A Guidance

FDA publishes an International Council for Harmonization question-and-answer guidance responding to questions about its M10 bioanalytical method valid...

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Human Drugs

FDA Accelerated Approval for BMS Augtyro Cancer Drug

FDA grants accelerated approval to Bristol Myers Squibbs Augtyro to treat some adults and pediatric patients with neurotrophic tyrosine receptor kinas...