FDA reviewers dismiss new analyses and data from Amylyx that were intended to provide confirmatory evidence to support approval of its amyotrophic lat...
FDA issues a form FDA-483 with multiple inspection observations to Indias Biocon Biologics following three inspections at manufacturing sites in India...
Cue Health files a de novo marketing submission for its Cue Flu Molecular Test for at-home and point-of-care use.
The FDA FY 2021 GDUFA Science and Research Outcomes Report demonstrates how GDUFA research projects have contributed to the development of generic dru...
FDA says it is partnering with the Critical Path Institute to explore creating a Lysosomal Diseases Consortium as part of the Accelerating Rare Diseas...
FDA clears an eCential Robotics 510(k) for its 3D imaging, navigation and robotics guidance system for use in bone surgical procedures.
As it negotiates a consent decree over its ventilators and other airway devices with the Department of Justice (DoJ), the company agrees to settle Fal...
FDA says the Integra recall of 388 CereLink intracranial pressure monitors is Class 1.
