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...
FDA clears a Philips 510(k) for its new Spectral CT Verida system, which the company describes as the first AI-powered detector-based spectral CT scan...
FDA posts a draft guidance outlining how drugmakers should establish impurity specifications for antibiotics produced by fermentation and semi-synthet...
FDA issues a draft guidance outlining a proposed compliance policy that could ease certain premarket requirements for respirators already approved by ...
FDA has granted Opna Bio a fast track designation for its investigational therapy OPN-6602 and its use in treating patients with relapsed or refractor...
