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...
Genentech submits a supplemental NDA for Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) in people with previously untreated chronic ...
Purdue rebuts a Massachusetts claim that it improperly marketed its opioid medications for long-term and high-dose use, citing FDA approval of the ind...