Health plans face challenges in risk arrangements for orphan drugs, but increasing competition may open doors for innovative ...

The One Big Beautiful Bill Act takes a big step in the rare disease space by expanding the contours of the orphan drug exclusion, a once ...

T O APPRECIATE the dilemmas the Food and Drug Administration (FDA) faces when it reviews new drugs targeting rare diseases, ...

The Drug Discovery Services Companies Quadrant provides an in-depth analysis of the drug discovery services market, highlighting key players, technological advancements, and trends. Conducted by ...

SAR446523, an investigational antibody targeting GPRC5D, received FDA orphan drug status and is in phase 1 trials for ...

Kedrion is proud to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to ...

Precision BioSciences Inc., a clinical-stage company developing gene editing therapies for diseases with high unmet need, has ...

FDA granted Orphan Drug Designation to Sanofi’s SAR446523, a monoclonal antibody targeting GPRC5D, for relapsed/refractory ...

The legal battle over the scope of orphan drug exclusivity continues, as the U.S. Food and Drug Administration (“FDA”) has recently lost a second ...

Sanofi's SAR446523 gains FDA orphan drug status, offering hope for relapsed multiple myeloma patients with its targeted ...

In April 2025, the FDA granted orphan drug designation to spesolimab-sbzo for the treatment of pyoderma gangrenosum. This ...