The U.S. FDA issued a complete response letter in October 2023 for Dupixent (dupilumab) in treating chronic hives but has now approved the monoclonal antibody for the indication. The approval makes Dupixent the first targeted biologic the agency has approved in the past 11 years for chronic spontaneous urticaria. Read More
Watchers of the percolating myasthenia gravis space are waiting eagerly for data from Dianthus Therapeutics Inc.’s phase II Magic study testing DNTH-103, an active C1s inhibitor, compared to placebo in patients with anti-AChR-positive generalized disease. Read More
Nearly three weeks into the job, U.S. FDA Commissioner Marty Makary provided a comprehensive overview of his vision for the much-reduced agency, even as he’s taking first steps to implement his agenda. Read More
The U.S. FDA cleared 21 drugs for market in March, topping 16 approvals granted in February and 12 in January. That brought the first quarter (Q1) total to 49 approvals, just one short of the 50 logged in Q1 2024, making it the second-highest Q1 count in BioWorld’s records. Read More
First quarter earnings reports from Johnson & Johnson and Abbott Laboratories provided some surprising insights into the likely hit med-tech companies will sustain with current tariffs. The main takeaway? The impact of the trade war with China is far greater than expected by most analysts. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Addex, Bighat, Channel, Eli Lilly, Evotec, Janssen, Johnson & Johnson, Ligand, Pelthos. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bavarian Nordic, GSK, Pfizer, Regeneron, Scilex, Uniqure. Read More
