FDA issues a draft guidance entitled Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and L...
Consultant Erika Roberts says FDAs rollout of its staff AI tool Elsa is a good first step, but much more needs to be done to reach the potential of us...
FDA approves a Sirtex Medical PMA for its SIR-Spheres Y-90 resin microspheres for treating unresectable hepatocellular carcinoma.
A group of medical societies files suit against HHS secretary Robert F. Kennedy Jr. and FDA commissioner Marty Makary to reverse a 5/27 decision to re...
A new FDA report examines the demographic representation of clinical trials supporting the approval of 50 novel drug therapies last year.
FDA removes risk evaluation and mitigation strategies requirements for all currently approved CAR T cell therapies, saying the programs have burdened ...
UCB reports positive data from a Phase 3 clinical trial evaluating fenfluramine as an adjunctive treatment for rare epileptic encephalopathy condition...
An appeals court rules for FDA that a clinically superior drug is not the same as a drug that is otherwise the same.
