FDA Review posts product approval summaries for the week ending 11/25/2016.
uno Therapeutics faces another setback on pushing its CAR-T cell product candidate through the development process after the company placed its ROCKET...
FDA issues Green Cross Corp. a complete response letter on its BLA for IVIG-SN (human normal immunoglobulin G for intravenous administration), intende...
CDER director Janet Woodcock says drug developers must use the entire clinical development program and not just a trial to answer some key questions.
Federal Register Final Rule: FDA amends its nonprescription drug regulations to supplement the time and extent application (TEA) process by establishi...
Federal Register Notice: FDA makes available a guidance entitled Nonprescription Sunscreen Drug Products Format and Content of Data Submissions.
Federal Register Notice: FDA makes available a guidance on Nonprescription Sunscreen Drug Products Safety and Effectiveness Data.
Eli Lilly says solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial, a Phase 3 study in people with mild dementia due to Al...