Pharma & Biotech - Page 15

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

Ipsen has announced that its Bylvay drug has failed to meet the primary endpoint in a major Phase 3 clinical trial targeting biliary atresia in young children. The French pharmaceutical company revealed

India-based active pharmaceutical ingredient makers Jagsonpal Pharmaceuticals and Tyche Industries have each received warning letters from the US Food and Drug Administration. Both companies were also placed on the FDA’s import alert

BeOne Medicines is investing $300 million into its flagship New Jersey campus to expand domestic drug manufacturing with new small molecule production capabilities. The investment targets the company’s Princeton West Innovation Campus

Roche is defending its ambitious long-term revenue forecasts for eye drug Vabysmo after the treatment fell short of analyst expectations for another quarter. Second-quarter sales of Vabysmo came in at approximately 1.04