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.

Pfizer and Innovent Biologics have signed a 10.5 billion dollar global collaboration covering 12 early-stage oncology programs.

USP annual drug shortages report reveals average shortage durations have reached 5 years, product discontinuations surged 60 percent, and 44 percent of drugs in shortage depend on single-country key starting materials.