FDA approves Bristol Myers Squibbs Opdivo (nivolumab) in combination with platinum-doublet chemotherapy as neoadjuvant treatment of adults with resect...
FDA denies an Amneal Pharmaceuticals petition asking the agency to take several actions involving Provells Euthyrox (levothyroxine sodium).
FDA clears an OrthAlign 510(k) for its Lantern Hip handheld technology for direct anterior total hip arthroplasty in patients in the supine position.
Aldeyra Therapeutics resubmits an NDA for topical ocular reproxalap, an investigational new drug for treating signs and symptoms of dry eye disease.
Four stakeholders ask for clarifications and revisions in an FDA draft guidance on essential drug delivery outputs for devices intended to deliver dru...
FDA says a Philips Respironics software correction for several ventilators was a Class 1 recall.
FDA releases the form FDA-483 with seven observations issued following an inspection at the Lorton, VA-based Annovex Pharma outsourcing facility.
FDA approves GE HealthCares Flyrcado (flurpiridaz F 18) injection, a positron emission tomography myocardial perfusion imaging agent for detecting cor...
