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Human Drugs

Provention Bio Diabetes Delayer Approved

FDA approves a Provention Bio BLA for Tzield (teplizumab-mzwv) injection and its use in delaying onset of Stage 3 Type 1 diabetes in certain adults an...

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Human Drugs

Inspections Focusing on Management Responsibility: FDA

FDA Office of Regulatory Affairs Division of Pharmaceutical Quality Operations III program director Jeffrey Meng tells an industry conference that upc...

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Human Drugs

Pfizer/BioNTech on Encouraging Covid Booster Data

Pfizer and BioNTech announce results showing that their current authorized bivalent booster vaccine provides a greater increase in neutralizing antibo...

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Biologics

Iovance Pushes Back BLA for Melanoma Therapy

Iovance Biotherapeutics delays its completion of a rolling BLA submission for lifileucel, an investigational tumor infiltrating lymphocyte therapy for...

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Federal Register

Animal Drug User Fees Reauthorization Meeting

Federal Register notice: FDA announces a 12/7 public meeting entitled Animal Drug User Fee Act to discuss reauthorizing the user fee program.

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FDA General

Bernie Sanders to Head HELP Committee

Senator Bernie Sanders (I-VT) looks to become chairman of the Health, Education, Labor and Pensions (HELP) Committee after current chair Patty Murray ...

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Human Drugs

Guidance on Compounding Amoxicillin Due to Shortages

FDA issues an immediately in effect guidance on the preparation of beta-lactam oral antibiotic suspension products compounded by pharmacists that are ...

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Federal Register

FDA Withdraws 10 No-Longer-Marketed ANDAs

Federal Register notice: FDA withdraws approval of 10 ANDAs from multiple applicants after they told the agency the products were no longer marketed.

Human Drugs

Comments Sought on Proposed NDC Revision

CDER lead consumer safety officer Leyla Rahjou-Esfandiary says the agency wants to receive comments by 11/22 on its proposal to increase the National ...

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Human Drugs

FDA Warns 7 Supplement Companies About CV Claims

FDA warns seven dietary supplement manufacturers they are illegally selling products that claim to treat cardiovascular disease.