The FDA recently granted EXG-34217 Rare Pediatric Disease Designation (RPDD) and Regenerative Medicine Advanced Therapy (RMAT) Designation.

The evolution of cell and gene therapy is reshaping drug discovery, providing new hope for rare diseases and cancer through innovative gene editing approaches.

First of many site approvals, including sites in the US, Europe and the Middle East, expected throughout Q1-Q3 2025 Company remains on track for first subject treated in pivotal, adaptive Phase 3 ...

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) and rare paediatric disease designation (RPDD) to Arbor Biotechnologies' gene editing therapeutic, ABO-101, to treat ...

In order to raise essential awareness about the devastating effects of drug abuse among the members of the association, the Erode District Chemists and Druggist Association (Erode CDA) will organise ...

Ac-satoreotide is a first-in-class Actinium-labelled somatostatin receptor 2 antagonist targeting extensive-stage Small Cell Lung Cancer or Merkel Cell Carcinoma Orphan Drug Designation follows ...

has granted Orphan Drug Designation (ODD) to 225 Ac-SSO110 (satoreotide) for the treatment of patients with Small Cell Lung Cancer (SCLC). SCLC is a deadly condition that represents a significant ...

has granted Orphan Drug Designation (ODD) to 225 Ac-SSO110 (satoreotide) for the treatment of patients with Small Cell Lung Cancer (SCLC). SCLC is a deadly condition that represents a significant ...

has granted Orphan Drug Designation (ODD) to its proprietary radiopharmaceutical, 225Ac-satoreotide, for treating patients with Small Cell Lung Cancer (SCLC). SCLC is a severe condition with a poor ...

It is similar to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of sections 514 and 515 of the Food, Drug and Cosmetic ... review of a HUD designation ...