Uncategorized

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 …

FDA Issues Final Guidance on Promotional Labeling and Advertising Considerations for Reference, Biosimilar, and Interchangeable Biosimilar Products Read More »

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 »

The U.S. Food and Drug Administration (FDA) has released the 2025 Accelerating Rare disease Cures (ARC) Program Annual Report. Since its launch in 2022, the Center for Drug Evaluation and Research (CDER) ARC Program continues to be a key resource for the rare disease community and a driver of innovative approaches for rare disease drug development. …

FDA Releases 2025 CDER ARC Program Annual Report Read More »

Regeneron Pharmaceuticals and Tessera Therapeutics are collaborating to advance a promising in vivo gene editing therapy for alpha-1 antitrypsin deficiency (AATD).

Johnson & Johnson’s immunoselective monoclonal antibody Imaavy (nipocalimab) has been approved by the European Commission to treat individuals with generalised myasthenia gravis (gMG) 12 years old and over.

On December 3, 2025, the Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. In 2023, FDA granted accelerated approval to pirtobrutinib for adults with CLL/SLL who have …

FDA grants traditional approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma Read More »

Otsuka Receives FDA Accelerated Approval for VOYXACT® (sibeprenlimab-szsi) for the Reduction of Proteinuria in Adults with Primary Immunoglobulin A Nephropathy (IgAN) at Risk for Disease Progression