FDA approves a Medtronic PMA for its Harmony Transcatheter Pulmonary Valve, the first minimally invasive therapy to treat patients with a specific typ...
CDRH officials reflecting on Covid-19 experience say at-home diagnostics will accelerate technological advances that benefit routine medical care and ...
An FDA advisory committee votes 19 to 1 that a Pfizer-proposed Risk Evaluation and Mitigation Strategy in its BLA for osteoarthritis drug tanezumab su...
FDA requires Glaxo to add information to the Shingrix labeling on an association between the shingles vaccine and Guillain-Barr Syndrome.
Attorney Sarah Cork describes an Arbor Pharmaceuticals suit challenging an FDA determination that the companys withdrawal of its original Nymalize was...
FDA asks for changes to Benzedrex OTC decongestant inhalers to reduce the likelihood of abuse and misuse.
Alembic Pharmaceuticals recalls one lot of telmisartan tablets, USP, 20 mg, packaged in 30-count bottles due to a mislabeling concern.
AstraZeneca revises its Covid-19 clinical trial vaccine efficacy rate from 79% to 76% under a primary analysis after the studys data and safety monito...