Lilly presented Phase III data for Jaypirca (pirtobrutinib) at the European Hematology Association (EHA) 2026 annual meeting in Stockholm, demonstrating for the first time that a three-drug combination can outperform a venetoclax-containing control regimen in relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
While the data are promising and gives Lilly an edge in CLL/SLL, the window for the US drugmaker to capitalize...
An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
