Samsung Biologics 353 million acquisition of GSK biologics manufacturing facility in Rockville Maryland marks the Korean CDMO giant first U.S. production presence and signals a strategic inflection in the global CDMO landscape.

Pfizer and Innovent Biologics have struck one of the largest oncology licensing deals in pharmaceutical history, committing up to $10.5 billion for a 12-program cancer portfolio spanning antibody-drug conjugates and multispecific antibodies.

The U.S. FDA has issued Import Alert 66-80, authorizing detention without physical examination of foreign-sourced GLP-1 receptor agonist APIs, following the discovery of a neurotoxic impurity in generic semaglutide and tirzepatide batches.

The U.S. FDA has approved Lupin Limited's Ranluspec (ranibizumab-hkdz) as the fourth interchangeable biosimilar referencing Genentech's Lucentis, offering expanded treatment options for retinal disease patients.