Eli Lilly reports study results showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheime...
BridgeBio Pharma plans to file an NDA after reporting positive results from ATTRibute-CM, a Phase 3 study of acoramidis in transthyretin amyloid cardi...
Federal Register notice: FDA and the Clinical Trials Transformation Initiative seek patient advocates interested in participating on the Patient Engag...
FDA issues Fresenius Kabis Canton, MA outsourcing facility a Form FDA-483 over GMP deviations observed during a March inspection.
FDA clears a MedRhythms 510(k) for InTandem, a neurorehabilitation system to improve walking and ambulation in stroke patients.
FDA clears an EarliTec Diagnostics 510(k) for the second generation of its EarliPoint Evaluation for Autism Spectrum Disorder in children ages 16 to 3...
Senators Mike Lee (R-UT), Ben Ray Lujn (D-NM), Mike Braun (R-IN), and J.D. Vance (R-OH) introduce a bill to ease biosimilar interchangeability.
Federal Register notice: FDA makes available a draft guidance entitled Manufacturing Changes and Comparability for Human Cellular and Gene Therapy (CG...
