FDA approves Mercks Idvynso, a once-daily, single-tablet regimen for adults with HIV-1 who are already virologically suppressed.
Outlook Therapeutics completes a formal dispute resolution meeting with FDA as part of the companys push to revive its approval prospects for ONS-5010...
FDA outlines expanded efforts to reduce animal testing in drug development after reporting significant first-year progress under its roadmap to modern...
President Trump signs an executive order aimed at accelerating the development and availability of psychedelic-based treatments for patients with seri...
FDA accepts for priority review a Pfizer and Astellas Pharma supplemental BLA for Padcev (enfortumab vedotin-ejfv) that seeks to expand its use for p...
FDA updates a guidance clarifying how patients, physicians, and drug developers can access investigational therapies outside of clinical trials, incor...
Nektar Therapeutics reports new 52-week data from its mid-stage REZOLVE-AA trial, showing continued improvement in hair regrowth among patients with s...
FDA tells Passage Bio that a randomized controlled trial will be required to support approval of its experimental gene therapy for a rare form of deme...
