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Last updated about 13 hours ago

FDA approves drug for adult and pediatric patients aged 6 and older with allergic fungal rhinosinusitis

about 13 hours ago

The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for...

Notable Approvals | Drugs

about 14 hours ago

News about human drug-related approvals

Publications from Office of Biostatistics Staff

about 14 hours ago

Publications from Office of Biostatistics Staff

Ongoing | Cancer Accelerated Approvals

about 15 hours ago

This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications...

Verified Clinical Benefit | Cancer Accelerated Approvals

about 15 hours ago

This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications...

FDA grants traditional approval to encorafenib for metastatic colorectal cancer with a BRAF V600E mutation

about 17 hours ago

FDA grants traditional approval to encorafenib for metastatic colorectal cancer with a...

CDER Guidance Agenda

about 19 hours ago

CDER Guidance Agenda

MedisourceRx - 717970 - 12/12/2025

about 20 hours ago

Compounding Pharmacy/Adulterated Drug Products

A. Nelson & Co. Ltd. - 720283 - 02/12/2026

about 20 hours ago

CGMP/Finished Pharmaceuticals/Adulterated

AQ USA Inc., d.b.a Ross Healthcare Inc. - 719517 - 02/12/2026

about 20 hours ago

CGMP/Finished Pharmaceuticals/Adulterated

Guidance Documents for Rare Disease Drug Development

1 day ago

Guidance Documents for Rare Disease Drug Development

Division of Applied Regulatory Science

2 days ago

The Division of Applied Regulatory Science is located within FDA’s Office of...