On December 17, 2025, the Food and Drug Administration (FDA) approved rucaparib (Rubraca, pharmaand GmbH) for adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) previously treated with an androgen receptor-directed therapy. Patients should be selected for therapy using an FDA-approved companion diagnostic (CDx).
Positive topline results from Hong Kong-based Ascletis Pharma’s ongoing phase I US clinical trial indicate the best-in-class potential of its oral small molecule IL-17 inhibitor ASC50.
The US Food and Drug Administration (FDA) has approved Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with Perjeta (pertuzumab) as the first new first-line treatment in ten years for HER2-positive metastatic breast cancer.
U.S. Food and Drug Administration issued two final guidances, “Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices” and “Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.”
The U.S. Food and Drug Administration (FDA) has approved Cardamyst (etripamil) nasal spray to treat episodes of paroxysmal supraventricular tachycardia (PSVT), a condition where the heart beats abnormally fast.
U.S. Food and Drug Administration issued the final guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers.” This guidance addresses questions that manufacturers, packers, distributers, and their representatives may have when developing FDA-regulated promotional communications for prescription biological reference products and biosimilar products, including …
The second European Sales and Use of Antimicrobials for Veterinary Medicine (ESUAvet) annual surveillance report is now published, consolidating data from the EU including Iceland and Norway in 2024. Together with the report a new dashboard is launched allowing public access to data on the sales of antimicrobial veterinary medicinal products (VMPs) across the EU.
The U.S. Food and Drug Administration (FDA) has qualified the first AI drug development tool, the AI-Based Histologic Measurement of NASH (AIM-NASH), to help pathologists assess metabolic dysfunction-associated steatohepatitis (MASH) disease activity in clinical trials. This cloud-based tool helps pathologists score liver biopsy components, including fat infiltration (steatosis), inflammation (hepatocellular ballooning and lobular inflammation), and scarring …
FDA Qualifies First AI Drug Development Tool, Will Be Used in ‘MASH’ Clinical Trials Read More »
