The Molecular Logic Behind Roche’s Colon Cancer Priority Review That No One Is Explaining
Roche's FDA Priority Review for Tecentriq in dMMR/MSI-H stage III colon cancer has an October 9 decision date. Here's...
FDA Priority Review
FDA’s Priority Review Acceptance for Giredestrant NDA Sets a November 2026 Decision Clock for the Adjuvant SERD Market
FDA accepted Roche's giredestrant NDA under Priority Review on June 2, 2026—targeting a November 2026 action date for the...
Sanofi’s Venglustat Priority Review Is a Rare Disease Pricing License, Not Just a Clinical Win
FDA's 6-month priority review clock for Sanofi's venglustat in type 3 Gaucher disease—affecting fewer than 1,000 Americans—sets up one...