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Latest posts
Last updated about 1 hour ago
FDA grants accelerated approval to zongertinib for unresectable or metastatic non-squamous non-small cell lung cancer
about 1 hour ago
FDA granted accelerated approval to zongertinib, a kinase inhibitor, for an expanded...
Why Protecting Confidential Information is Key to the FDA’s "Gold Standard"
about 2 hours ago
The FDA must maintain a delicate balance: being a model of openness...
Internet Pharmacy Warning Letters
about 4 hours ago
Rogue online pharmacies offer potentially dangerous prescription drugs to U.S. consumers. FDA...
Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
about 5 hours ago
Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors...
Withdrawn | Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals
about 23 hours ago
This listing includes accelerated approvals (AAs) for non-malignant hematological, neurological, and other...
Ongoing | Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals
about 23 hours ago
Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint
Accelerated Approval Program
about 23 hours ago
To allow for earlier approval of drugs that treat serious conditions and...
FDA approves drug for adult and pediatric patients aged 6 and older with allergic fungal rhinosinusitis
2 days ago
The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for...
Publications from Office of Biostatistics Staff
2 days ago
Publications from Office of Biostatistics Staff
Ongoing | Cancer Accelerated Approvals
2 days ago
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications...