Atossa Therapeutics receives US Food and Drug Administration (FDA) Rare Pediatric Disease designation for (Z)-Endoxifen in McCune-Albright syndrome, qualifying for Priority Review Voucher award upon approval.
Atossa Therapeutics | 05/05/2026 | By News Bureau
Atossa Therapeutics Receives FDA Orphan Drug Designation for Duchenne Therapy
Atossa Therapeutics has received US Food and Drug Administration (FDA) Orphan Drug Designation (ODD) for (Z)-Endoxifen for the treatment of Duchenne Muscular Dystrophy, further supporting the company’s development programme in rare paediatric neuromuscular diseases.
Atossa Therapeutics | 17/01/2026 | By News Bureau | 128
Atossa Therapeutics Receives FDA Go-Ahead for (Z)-Endoxifen IND in Metastatic Breast Cancer
Atossa Therapeutics announced that it has received a “Study May Proceed” letter from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for (Z)-endoxifen in metastatic breast cancer, clearing the way for the initiation of clinical studies evaluating the therapy.
Atossa Therapeutics | 07/01/2026 | By News Bureau | 231
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