A novel off-the-shelf CAR-T cell therapy developed by researchers at Washington University School of Medicine in St. Louis receives an FDA breakthroug...
FDA's more aggressive approach to publicizing its criticisms of drugmakers draws both praise from investors and concern across the pharmaceutical indu...
The Washington Times publishes an opinion piece that draws attention to growing criticism of FDA commissioner Marty Makary.
Medtronic wins 510(k) clearance for its Stealth AXiS surgical system in cranial and ear, nose and throat procedures.
FDA gives Rocket Pharmaceuticals an accelerated approval for its gene therapy Kresladi (marnetegragene autotemcel) for children with severe Leukocyte ...
FDA sends an untitled letter to STAQ Pharma of Ohio, citing significant manufacturing, quality control, and labeling violations.
FDA releases a final guidance titled Incorporating Voluntary Patient Preference Information (PPI) Over the Total Product Life Cycle.
Erbe USA recalls its flexible cryoprobes due to their potential to rupture during activation, which could result in severe injury or death.
