The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for vatiquinone for the treatment of children and ...

The U.S. Food and Drug Administration (FDA) has accepted for filing PTC Therapeutics’ New Drug Application (NDA) for ...

PTC Therapeutics (PTCT) announced that the U.S. Food and Drug Administration, FDA, has accepted for filing the New Drug Application, NDA, for ...

PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for vatiquinone for the treatment of ...

3. Vatiquinone for Friedreich's Ataxia: This treatment has shown promise, particularly for pediatric patients not approved for Skyclaris. An NDA submission is planned for late 2024. 4. Translarna ...

As a biosimilar to Actemra, tocilizumab-anoh in both IV and SC formulation is approved to treat rheumatoid arthritis, pJIA, sJIA, COVID-19, and giant cell arteritis. The FDA recently approved ...