FDA says the Becton Dickinson recall of three intraosseous medical devices is Class 1.
The Menarini Group, supported by Radius Health, submits an NDA to FDA for elacestrant to treat some breast cancers.
The UMass Chan Medical School says the results of its study of at-home Covid tests are in an FDA recommendation for serial testing to help prevent mis...
The federal court hearing a proton-pump inhibitor liability consolidated case is considering whether a former FDAer who was involved in regulating the...
FDA grants full approval to Novartis for its previously accelerated-approved Tabrecta (capmatinib) for treating certain adult patients with metastatic...
FDA clears a ClearPoint Neuro 510(k) for its ClearPoint Maestro Brain Model, software that uses MRI images to conduct labeling, visualization, volumet...
Two stakeholders raise concerns about an FDA draft guidance on risk management programs to mitigate drug shortage potential.
The Colorado Society of Addiction Medicine says the labeling for buprenorphine products to treat opioid use disorder should be changed to recognize th...
