The U.S. FDA has accepted for review Telix Pharmaceuticals Ltd’s resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine, 18F-FET), its radiolabeled glioma imaging product for characterizing progressive or recurrent glioma in adult and pediatric patients. The FDA assigned a Sept. 11, 2026, PDUFA date.

South Korea is rolling out regulatory changes to speed biosimilar development, including reforms to shorten review timelines, ease phase III trial requirements and simplify oversight of manufacturing changes. 

Amplia Therapeutics Ltd. has halted recruitment in its phase II Amplicity trial in advanced pancreatic cancer due to three dose-limiting toxicities related to the chemotherapy regimen, modified FOLFIRINOX (mFOLFIRINOX), which is being administered in combination with lead compound narmafotinib (AMP-945), a focal adhesion kinase inhibitor.

After nearly a year of threats and promises of a global biopharma tariff of 25% to 500%, U.S. President Donald Trump finally delivered it. In the name of national security, he imposed a 100% sector tariff on prescription drugs and their associated ingredients beginning in about four months for large manufacturers and six months for smaller companies.

Total biopharma financings reached $25.14 billion in the first quarter (Q1) of 2026, nearly doubling the $13.12 billion in the Q1 2025. The early 2026 total comes in above the $13.19 billion recorded in 2023 and $13.66 billion in 2022, though it remains below the $38.27 billion during the same period in 2021 and $47.25 billion in 2024.

Hematopoietic stem cell research over the past century has shown that leukemia may be driven by an invisible hand of inflammation. The bone marrow and inflammation, then, may hold the keys to preventing blood cancers, according to John E. Dick’s plenary session at the 2026 Korean Society of Hematology International Conference, held March 26, 2026.