Pharma & Biotech - Page 4

Otsuka’s Simtriyo has received FDA approval as a once-daily extended-release capsule for treating ADHD in adults and children aged six and older weighing at least 20 kg. The drug, known generically as

Arrowhead Pharmaceuticals has released compelling data from two phase 3 clinical trials, positioning the company as a serious contender in the severe hypertriglyceridemia treatment space. The results come less than a month

Summit Therapeutics has released updated overall survival data from its phase 3 HARMONi trial as the FDA moves toward a landmark decision on ivonescimab. The new analysis, based on a data cut-off

Samsung Biologics (KRX: 207940) has announced plans to acquire Swiss peptide manufacturer PolyPeptide in a deal worth approximately $1.8 billion, marking a landmark moment for South Korean biopharma. The transaction is described

GSK has secured its first-ever lung cancer drug approval after the US Food and Drug Administration cleared Jideytro, delivering a rapid return on the company’s major acquisition. The FDA approved the drug

Merck (NYSE: MRK) has unveiled a sweeping access strategy for alimatravir, an investigational once-monthly oral pill designed to prevent HIV-1 infection. The drug, also known as MK-8527, is being positioned as a

Novo Nordisk has escalated its legal fight against Eli Lilly, notifying a federal court of plans to seek a preliminary injunction blocking certain rival obesity drug advertisements. The Danish pharmaceutical giant filed

Amgen has submitted a comprehensive data and analyses package to the FDA as it fights to keep its rare-disease drug Tavneos on the U.S. market. The submission, filed on July 23, directly

On the second day of a two-day advisory meeting, FDA outside experts delivered their first rejection of the week, voting down emideltide for the 503A Bulk Drug Substances list. The FDA’s Pharmacy

Cencora is restructuring its entire distribution strategy to keep pace with the rapid growth of specialty pharmaceuticals and cold chain medicine demand. Senior Vice President of Global Supply Chain Brent Wilhelm says