FDA Related News

Medical Devices

Predetermined Change Control Plan Principles

FDA and two international regulatory partners state five guiding principles for predetermined change control plans in machine learning-enabled medical...

Animal Drugs

Embryll Marketing Unapproved Animal Drug: FDA

FDA says Embryll Life Sciences is illegally marketing Lanomax, an unapproved animal drug intended to treat cataracts in animals.

Human Drugs

FDA Clears NKGen IND for Alzheimers Cell Therapy

FDA clears an NK Gen IND trial for its Alzheimers disease cell therapy.

Human Drugs

Zhimeng Bio Gets Orphan Status for ALS Drug

FDA grants Shanghai-based Zhimeng Biopharma an orphan drug designation for its small-molecule KCNQ2/3 selective opener compound (CB03) for treating am...

Medical Devices

Medtronic PMA for Extravascular ICD Approved

FDA approves a Medtronic PMA for the Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defi...

Human Drugs

Genentechs Rozlytrek Gets Expanded Use

FDA grants Genentech accelerated approval for an expanded use for Rozlytrek (entrectinib) in treating pediatric patients older than one month with sol...

Medical Devices

Fresenius Recalls Some Hemodialysis Machines

Fresenius Medical Care recalls some of its 2008 Series Hemodialysis Machines because patients may be exposed to toxic compounds that leach from some p...

FDA Approves New Tibsovo Indication

FDA approves a new indication for Servier Pharmaceuticals Tibsovo to treat adults with some myelodysplastic syndromes as detected by an Abbott compani...

Biologics

Complete Response on Dupixent sBLA

FDA sends Sanofi and Regeneron a complete response letter on their supplemental BLA for Dupixent (dupilumab) and its use in chronic spontaneous urtica...

Medical Devices

Medtronic Warning on McGrath Video Laryngoscopes

FDA posts a Medtronic notice warning healthcare professionals about stolen defective McGrath MAC video laryngoscopes that have been offered for sale i...