FDA grants Paige.AI a breakthrough device designation for its artificial intelligence tools to help physicians diagnose and treat cancer.
The Medical Device Innovation Consortium releases a somatic reference sample landscape analysis report.
Attorney Eric Alexander says a 3rd Circuit Court of Appeals decision in Fosamax that has been appealed to the Supreme Court is having an impact in oth...
FDA releases the FDA-483 issued following an inspection at Brookfield Medical/Surgical Supply.
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...