Zydus gains FDA Priority Review for saroglitazar as PBC treatment competition intensifies
Zydus’ saroglitazar gets FDA Priority Review in PBC, setting up a key test for dual PPAR therapy in rare liver disease.
Why Bayer’s HYRNUO first-line FDA review could reshape HER2-mutated NSCLC treatment sequencing
Bayer has FDA momentum in HER2-mutated lung cancer. The harder test is whether HYRNUO can move earlier without stronger survival data.
Hansa Biopharma files BLA for imlifidase in kidney transplant desensitization: What this changes for U.S. patients
Hansa Biopharma files for FDA approval of imlifidase to enable kidney transplants in highly sensitized patients. Find out what changes next.
How Hansa Biopharma is targeting a transplant blind spot with Imlifidase
Hansa Biopharma AB has submitted a Biologics License Application to the U.S. Food and Drug Administration for imlifidase as a desensitization treatment in highly sensitized adult patients awaiting deceased donor kidney transplants. The submission is supported by the pivotal Phase 3 ConfIdeS trial, and the company is seeking a priority review that could lead to […]