FDA clears a MaxQ AI 510(k) for its Accipio Ix intracranial hemorrhage detection software.
Federal Register notice: FDA submits to OMB a revised information collection on Postmarketing Adverse Drug and Biological Product Experience Reporting...
FDA grants Karyopharm Therapeutics a fast track designation for selinexor, the companys first-in-class, oral Sine compound for treating certain patien...
Five major drug companies suggest changes to an FDA draft guidance on using placebo controls in cancer clinical trials.
FDA releases the FDA-483 with seven observations following an inspection at MedisourceRx.
Federal Register notice: FDA makes available a final guidance entitled Hypertension: Developing Fixed- Combination Drug Products for Treatment.
FDA clears an MRI Interventions 510(k) for its latest software platform, ClearPoint 2.0.