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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.

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Human Drugs

FDA Approves Lilly Interchangeable Insulin Product

FDA approves Lillys Rezvoglar as the second interchangeable biosimilar insulin product.

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Human Drugs

9 Senators Want FDA Medication Abortion Action

Nine Democratic senators ask FDA to take three steps to protect and expand access to medication abortions.

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Human Drugs

Advisors Back Ardelyx Kidney Disease Drug

Members of the FDA Cardiovascular and Renal Drugs Advisory Committee vote to recommend approval of Ardelyx tenapanor for a kidney disease indication. ...

Biologics

Pfizer/BioNTech Studying Next Gen Covid Vaccine

Pfizer and BioNTech begin a Phase 1 study of their next-generation Covid-19 vaccine that they say is designed to enhance SARS-CoV-2 T cell responses a...

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Human Drugs

Pazdur Puts Foot Down on Single Country Trials

FDA Oncology Center of Excellence director Richard Pazdur says data from multiregional trials that represent the major International Conference for Ha...