Vanda Pharmaceuticals asks the DC federal court to set aside an FDA determination that the companys tradipitant does not qualify for a fast track desi...
FDA clears a RapidAI 510(k) for its Rapid PE Triage & Notification product for identifying a suspected central pulmonary embolism.
FDA places a clinical hold on an INmune Bio Phase 2 trial for XPro 1595, a next-generation inhibitor of tumor necrosis factor (TNF) that is designed t...
FDA releases the FDA-483 with six observations from an inspection at Indias Aurobindo Pharma drug manufacturing facility.
Four medical device stakeholders voice general support for an FDA proposal to harmonize the medical device Quality System Regulation with an internati...
CDER researchers describe a study of mouth-throat models for generic metered-dose inhalers to help generic inhaler manufacturers more efficiently test...
FDA says Teva recalled one lot of anagrelide capsules due to dissolution test failure.
Federal Register notice: FDA makes available a draft guidance entitled Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatme...