LOGO
LOGO

Genentech Reports FDA Acceptance Of Vismodegib NDA For Priority Review

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

Genentech, a subsidiary of Roche Holding AG (ROG.VX, RHHBY.PK), Wednesday reported the acceptance by the US Food and Drug Administration, or FDA, of its new drug application, or NDA, for vismodegib as a therapy for basal cell carcinoma in adults who cannot undergo surgery. The company also reported the application receiving a Priority Review status, with an action date of March 8, 2012.

The application is based on a Phase II study dubbed ERIVANCE which showed that vismodegib, which inhibits signaling in the Hedgehog Pathway, caused tumors to shrink substantially, or cured any visible lesions in basal cell carcinoma, or BCC patients. There are current FDA-approved medicines for BCC.

For comments and feedback contact: editorial@rttnews.com

Global Economics Weekly Update - Jun 01 - Jun 05, 2026

June 05, 2026 16:18 ET
A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.

Latest Updates on COVID-19