FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer
On December 17, 2025, the Food and Drug Administration (FDA) approved rucaparib (Rubraca, pharmaand GmbH) for adults with a deleterious…
C3TI Compass (Knowledge Repository)
Centralized knowledge repository for clinical trial innovation
Identification and Structural Elucidation of a New Synthetic Cannabinoid, MDMB‐5′Br‐PINACA, in Seized Herbal Materials
MDMB-5Br-PINACA, a novel synthetic cannabinoid, was identified and structurally characterized in seized herbal products using GC-MS, LC-HRMS, and NMR. The…
Heparin Importation
Therefore, in order to ensure that batches of imported heparin continue to meet regulatory standards, FDA is requiring that all…
Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices
Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices
FDA Drug Competition Action Plan | Improving the efficiency of the generic drug development, review, and approval process
By clarifying FDA’s regulatory expectations for new entrants and experienced drug developers alike, FDA is supporting prospective generic drug developers…
ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs
ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs
Zydus Lifesciences Limited – 685224 – 12/09/2025
CGMP/Finished Pharmaceuticals/Adulterated
Zydus Lifesciences Limited – 685224 – 08/29/2024
CGMP/Finished Pharmaceuticals/Adulterated
3D Imaging Drug Design and Development LLC – 716213 – 12/04/2025
CGMP/Positron Emission Tomography (PET) Drugs/Adulterated