FDA
Final FDA Guidance Lays Path for Drugmakers to Establish Circulating Tumor DNA as Trial Endpoint
The guidance provides the agency's thoughts on the emerging use of ctDNA residual disease testing to select patients for treatment in trials of new adjuvant therapies.
European Commission Approves BeiGene's Tevimbra, Chemo in First-Line Gastric, Esophageal Cancers
The EC considered the treatment's activity in patients with advanced, PD-L1-positive esophageal and gastric cancers in the RATIONALE-305 and -306 trials.
In Brief This Week: Hemogenyx, Intellia, Care Access
News items for the week of Nov. 25, 2024.
FDA Approves Roche CDx Test for Use With Jazz Pharmaceuticals Drug in Biliary Tract Cancer
The approval is for a new indication for Roche's existing Pathway HER2 (4B5) test and is intended to identify patients with HER2-positive biliary tract cancer.
Neurogene Halts Testing High-Dose Rett Syndrome Gene Therapy After Adverse Event
Following this update, the company's stock price dropped more than 30 percent from market close Friday to $23.79 per share Monday morning.