FDA accepts two Allergan supplemental BLAs to expand its Botox (onabotulinumtoxin A)label for treating pediatric patients with upper and lower limb sp...
Allergan says Phase 3 trials of its rapastinel as an adjunctive therapy for major depressive disorder failed to meet primary and key secondary endpoin...
FDA accepts for review a Genentech supplemental NDA for Xofluza (baloxavir marboxil) as a single-dose, oral treatment for people at high risk of compl...
FDA updates a safety alert that warned health professionals about Zoll Medicals Zoll LifeVest 4000 Wearable Cardioverter Defibrillator due to concerns...
Federal Register notice: FDA seeks comments on its announced intention to exempt certain flow cytometer instruments from premarket notification requir...
Researchers say drug sponsors and FDA can do a better job of communicating non-efficacy benefits arising from non-inferiority trials.
FDA clears a CurvaFix 510(k) for the CurvaFix Intramedullary Rodscrew for use in pelvic trauma surgery.
FDA clears an Instrumentation Laboratory 510(k) for the GEM Premier ChemSTAT in vitro diagnostic analyzer with Intelligent Quality Management.