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priority review

PharmaDeviceNews priority review
Representative image of liver disease drug research and clinical data analysis. Zydus’ FDA Priority Review for saroglitazar highlights the growing treatment competition in primary biliary cholangitis.
Pharma & Biotech

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.

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Representative image: Clinicians reviewing lung cancer imaging and genomic test results, reflecting Bayer’s HYRNUO FDA Priority Review and the growing role of precision oncology in HER2-mutated non-small cell lung cancer treatment.
Pharma & Biotech

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.

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Pharma & Biotech

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.

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A representative image of a kidney prepared for transplant in a sterile surgical setting. As new desensitization therapies like Imlifidase advance toward FDA review, the promise of expanding access to organ transplantation for highly sensitized patients is gaining renewed attention.
Pharma & Biotech

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

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