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Last updated about 3 hours ago
Bioresearch Monitoring Information System (BMIS)
about 3 hours ago
Bioresearch Monitoring Information System (BMIS) background page with download file.
Drug Trials Snapshot: HYRNUO
3 days ago
HYRNUO is a tyrosine-kinase inhibitor that is indicated for the treatment of...
ULTRA ADVANC3 and ULTRA ADVANC3 GOLD may be harmful due to hidden drug ingredients
4 days ago
The Food and Drug Administration is advising consumers not to purchase or...
FDA grants accelerated approval to zongertinib for unresectable or metastatic non-squamous non-small cell lung cancer
4 days 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"
4 days ago
The FDA must maintain a delicate balance: being a model of openness...
Internet Pharmacy Warning Letters
4 days 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
4 days 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Withdrawn | Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals
5 days 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
5 days ago
Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint